• The Journal of KAIRB
• /
• v.2 no.2
• /
• pp.37-48
• /
• 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.

• Journal of Korean Academy of Nursing Administration
• /
• v.6 no.1
• /
• pp.135-146
• /
• 2000

The purpose of this study was to develope, based on the Nursing Intervention Classification (NIC) system. a set of standardized nursing interventions which had been validated. and their associated activities. for use with nursing diagnoses related to home health care for women who have had a caesarian delivery and for their newborn babies. This descriptive study for instrument development had three phases: first. selection of nursing diagnoses. second, validation of the preliminary home health care interventions. and third, application of the home care interventions. In the first phases, diagnoses from 30 nursing records of clients of the home health care agency at P. medical center who were seen between April 21 and July 30. 1998. and from 5 textbooks were examined. Ten nursing diagnoses were selected through a comparison with the NANDA (North American Nursing Diagnosis Association) classification In the second phase. using the selected diagnoses. the nursing interventions were defined from the diagnoses-intervention linkage lists along with associated activities for each intervention list in NIC. To develope the preliminary interventions five-rounds of expertise tests were done. During the first four rounds. 5 experts in clinical nursing participated. and for the final content validity test of the preliminary interventions. 13 experts participated using the Fehring's Delphi technique. The expert group evaluated and defined the set of preliminary nursing interventions. In the third phases, clinical tests were held at in a home health care setting with two home health care nurses using the preliminary intervention list as a questionnaire. Thirty clients referred to the home health care agency at P. medical center between October 1998 and March 1999 were the subjects for this phase. Each of the activities were tested using dichotomous question method. The results of the study are as follows: 1. For the ten nursing diagnoses. 63 appropriate interventions were selected from 369 diagnoses interventions links in NlC., and from 1.465 associated nursing activities. From the 63 interventions. the nurses expert group developed 18 interventions and 258 activities as the preliminary intervention list through a five-round validity test 2. For the fifth content validity test using Fehring's model for determining lCV (Intervention Content Validity), a five point Likert scale was used with values converted to weights as follows: 1=0.0. 2=0.25. 3=0.50. 4=0.75. 5=1.0. Activities of less than O.50 were to be deleted. The range of ICV scores for the nursing diagnoses was 0.95-0.66. for the nursing interventions. 0.98-0.77 and for the nursing activities, 0.95-0.85. By Fehring's method. all of these were included in the preliminary intervention list. 3. Using a questionnaire format for the preliminary intervention list. clinical application tests were done. To define nursing diagnoses. home health care nurses applied each nursing diagnoses to every client. and it was found that 13 were most frequently used of 400 times diagnoses were used. Therefore. 13 nursing diagnoses were defined as validated nursing diagnoses. Ten were the same as from the nursing records and textbooks and three were new from the clinical application. The final list included 'Anxiety', 'Aspiration. risk for'. 'Infant behavior, potential for enhanced, organized'. 'Infant feeding pattern. ineffective'. 'Infection'. 'Knowledge deficit'. 'Nutrition, less than body requirements. altered', 'Pain'. 'Parenting'. 'Skin integrity. risk for. impared' and 'Risk for activity intolerance'. 'Self-esteem disturbance', 'Sleep pattern disturbance' 4. In all. there were 19 interventions. 18 preliminary nursing interventions and one more intervention added from the clinical setting. 'Body image enhancement'. For 265 associated nursing activities. clinical application tests were also done. The intervention rate of 19 interventions was from 81.6% to 100%, so all 19 interventions were in c1uded in the validated intervention set. From the 265 nursing activities. 261(98.5%) were accepted and four activities were deleted. those with an implimentation rate of less than 50%. 5. In conclusion. 13 diagnoses. 19 interventions and 261 activities were validated for the final validated nursing intervention set.

• Journal of dental hygiene science
• /
• v.12 no.1
• /
• pp.7-13
• /
• 2012

Critical thinking is a essential competency for dental hygiene education and practice. The purpose of this study was to examine critical thinking disposition between groups classified by GPA score in two dental hygiene educational program. A total 252 dental hygiene students responded. The study extracted six dimensions(intellectual eagerness/curiosity, prudence, healthy skepticism, intellectual integrity, objectivity, self-confidence) derived from 27 items with the exception of systematicity using factor analysis. The mean score for critical thinking disposition was 3.47 on a 5 point scale. The result showed a statistically significant correlation critical thinking disposition and age. Multivariate analysis of covariance(MANCOVA) was used to compare six subscales between the three groups. MANCOVA results revealed that intellectual eagerness/curiosity for three groups were significantly different(Wilks's lamda=0.914, F(6, 24)=1.869), p=0.01, partial eta square=0.044). Multiple comparison for intellectual eagerness/curiosity by Scheffe's method showed differences between high score group and mid score group(p=0.027), high score group and low score group(p=0.002). In this study, academic achievement and critical thinking tends to show significant correlations is known. Critical thinking skills by examining the actual grade compares the difference in propensity scores according to a case study in intellectual curiosity, passion, and could tell the difference to appear.

• Journal of Home Health Care Nursing
• /
• v.3
• /
• pp.53-66
• /
• 1996

Home Health Care is one part of the total health care system. It includes health care services that link the hospital to the community. While it is important for early discharge patients, home care is also important for people with chronic illnesses or handicapping conditions. In 1989 the Korean government passed a law that opened the way for formal development of home health care services beginning with education programs to certify nurses for home care, and then demonstration home care services. Part of the mandate of the demonstration projects was evaluation of home care services. This study was done in order to provide basic data that would contribute to the development of records that could be used for evaluation through a retrospective audit and to examine the care that had been given in Home Care at Wonju Christian Hospital over a twenty year period from 1974 to 1994. The purposes of the study were : to identify to characteristics of the clients who had received home care, to identify the reasons for client referrals, to identify the nursing problems of these clients, to identify the nursing care provided to these clients, and to identify differences in these areas over the twenty year period. The study was a descriptive study involving a retrospective audit of the client records. Demographic data on all clients were included : 4,171 clients from 2,564 families. Data on referrals, nursing diagnosis and nursing interventions were from even numbered records which had a patient problem list included in the record, 2,801 clients, Frequencies and ANOVA were used in the analysis. The results of the study showed that the majority of the clients were from Wonju city /county. There were more women than men related to the high number of postpartum clients(1,300). The high number of postparttum clients and newborns was also evident in the age distribution. An the number of maternal-child clients decreased over the 20 years, the mean age of the clients increased significantly. Other factors also contributed to this change ; as increasing number of clients with brain injuries or with cancer, and fewer children with burns, osteomyelitis and tuberculosis. There was a decrease in the mean number of visits and mean length of coverage, reflecting a movement towards a short term acute care model. The number of new clents dropped sharply after 1985. The reasons for this are : the development of other treatment alternatives for clients, the establishment of an active wellbaby clinic, many more options plus a decreasing number of new cases of Hansen's Disase, and insurance that allows people with burns to be kept in hospital until skin grafts are healed. Socioeconomic changes have resulted in an increase in the number of cases of cancer, stroke, head injuries following car accidents, and of diabetes. Of the 2,801 client records, 2,541(60.9%) contained a written referral but for 1,802 it contained only the medical diagnosis. The number of records with a referral requesting specific nursing care was 739(29.1%). Many family members who were identified as in need of nursing care had no written referral. Analysis of the patient problem list showed that 41.9% of the enteries were nursing diagnoses. Others incuded medical diagnosis, symptoms, and plans. The most frequently used diagnoses were alteration in nutrition, less than body requirements(115 entries), alteration in skin integrity(114), knowledge deficit(111), pain(78), self-care deficit(66), and alteration in pattern of urinary elimination(50). These are reflected in the NANDA categories for which the highest number of diagnosis was in the Exchanging pattern(446), followed by Moving(178), Feeling(136) and Knowing (115). Analysis of the frequency of interventions showed that exercise and teaching about exercise was the most frequent intervention, followed by teaching concering the need for follow-up care, checking vital signs, managing nutritional problems, managing catheters, giving emotional support, changing dressings, teaching about medication, teaching (subject not specified), teaching about diet, IM and IV medications or fluid, and skin care, in that order. Recommendations included: development of a record that would allow for efficient recording of frequently used nursing diagnoses and nursing interventions: expansion of the catchment area for Home Care at Wonju Christian Hospital ; expansion of the service to provide complication prevention, rehabilitation services, and support to increase the health maintenance /health promotion of the people being served as well as providing client dentered care ; and development of a clinical record that will allow efficient data collection from records, even though the recording is done by a variety of health care providers.

• The Journal of the Korea Contents Association
• /
• v.16 no.7
• /
• pp.382-397
• /
• 2016

This study focuses on the lessons and implications of Germany's measures for the social integration after the reunification, and especially the Germany's measure on labor reproduction for the economic stability of East Germany. This analysis indicates, whether South Korea is going to achieve gradual and peaceful reunification or absorb North Korea due to its sudden collapse, that the reunification, in any case, requires the social integration through economic stability of both North and South. In order to ensure national reconciliation, recovery of homogeneity, and establishment of identity for the economically stable social integration, the new integration of educational system is necessary. Especially, the objective of this study is to find the role and direction of vocational education for the stability of the North Korea's labor market and economic life in order to socially integrate South Koreans with its Northern counterparts. First of all, this study examined a priori example of the experiences during West Germany's social integration process, i.e. the vocational education promotion process for the social stability and economic life. It figured out the problem of vocational education for the integrity as well as analyzed the vocational education differences and integration promotion system between East & West Germany. Even though East and West Germany showed their disparities in each vocational education, they corroborated each other by finding one similar system such as bifurcation, which lead to the integration of the labor market and new vocational education policy for the economic stability. Despite the West Germany's support for the socio-economic integration, nevertheless, the East Germany's capacity turned out to be insufficient, which resulted in the failure of the policy. Based on above discussion, this study intended to suggest the efficient solutions of vocational education for the internal reunification of South and North Korea by promoting the independence and self-support of North Koreans and leading the stability of labor market and economic for the future reunification.

• Journal of vocational education research
• /
• v.35 no.4
• /
• pp.131-153
• /
• 2016

The purpose of this study was to derive evaluator's role and capability for institution accreditation evaluation of NCS-based vocational competency development training. This study attempted to explore in various ways evaluator's minute roles using Delphi method, and to derive knowledge, skill, attitude and integrity needed to verify the validity. To the end, this study conducted the Delphi research for over three rounds by selecting education training professionals and review evaluation professions as professional panels. From the results, roles of evaluators were defined as the total eight items including operator, moderator-mediator, cooperator, analyzer, verifier, institution evaluator, institution consultant, and learner, and the derived capabilities with respect to each role were 25 items in total. The area of knowledge included four items of capabilities such as HRD knowledge, NCS knowledge, knowledge of vocational competency development training, and knowledge of training institution accreditation evaluation, and the area of skill comprised fourteen items of capabilities such as conflict management ability, interpersonal relation ability, word processing ability, problem-solving ability, analysis ability, pre-preparation ability, time management ability, decision making ability, information comprehension and utilization ability, comprehensive thinking ability, understanding ability of vocational competency development training institutions, communication ability, feedback ability, and core understanding ability. The area of attitude was summarized with the seven items in total including subjectivity and fairness, service mind, sense of calling, ethics, self-development, responsibility, and teamwork. The knowledge, skill and attitude derived from the results of this study may be utilized to design and provide education programs conducive to qualitative and systematic accreditation and assessment to evaluators equipped with essential prerequisites. It is finally expected that this study will be helpful for designing module education programs by ability and for managing evaluator's quality in order to perform pre-service education and in-service education according to evaluator's experience and role.

• Journal of Global Scholars of Marketing Science
• /
• v.18 no.2
• /
• pp.65-88
• /
• 2008

Since the implementation of economic reforms in 1978, the Chinese economy grows rapidly at an average annul growth rate of 9% over the post two decades. Franchising has been widely recognized as an important source of entrepreneurial activity. Trust is important in that it facilitates relational exchanges by permits partners to transcend short-run inequities or risks to concentrate on long-term profits or gains. In the relationship between the franchisors and franchisees, trust has been described as an important source of competitive advantage. However, little research has been done on the factors affecting trust in Chinese franchisor-franchisee relationships. The purpose of this study is to investigate what factors affect the trust in the franchise system in China, and to provide guidelines and insights to franchisors which enter Chinese market. In this study, according to Morgan and Hunt (1994), trust is defined as the extending when one party has confidence in an exchange partner's reliability and integrity. We offered a conceptual model of the empirical study. The model shows that the factors affecting the trust include franchisor's supports, communication, satisfaction with previous outcome and conflict. We also suggested the franchisor's supports and communication like to enhance the franchisee's satisfaction with previous outcome, and the franchisor's supports, communication and he franchisee's satisfaction with previous outcome tend to decrease conflict. Before the formal study, a pretest involving exploratory interviews with owners from three franchisees was conducted to make sure the questionnaire was relevant and clear to the respondents. The data were collected using trained interviewers to carry out personal interviews with the aid of an unidentified, muti-page, structured questionnaire. The respondents comprised of owners, managers, and owner managers of franchisee-owned food service franchises located in Beijing, China. Even though a total of 256 potential franchises were initially contacted, the finally usable sample consisted of 125 respondents. As expected, the sampling method was successful in soliciting respondents with waried personal and firm characteristics. Self-administrated questionnaires were used for all measures. And established scales were used to measure the latent constructs in this study. The measures tapped the franchisees' perceptions of the relationship with the referent franchisor. Five-point Likert-type scales ranging from "strongly disagree" (=1) to "strongly agree" (=7) were used throughout the constructs (trust, eight items; support, five items; communication, four items; satisfaction, six items; conflict, three items). The reliability measurements traditionally employed, such as the Cronbach's alpha, were used. All the reliabilities were greater than.80. The proposed measurement model was estimated using SPSS 12.0 and AMOS 5.0 analysis package. We conducted A series of exploratory factor analyses and confirmatory factor analyses to assess the convergent validity, discriminant validity, and reliability. The results indicate reasonable overall fits between the model and the observed data. The overall fit of measurement model were $X^2$= 159.699, p=0.004, d.f. = 116, GFI =.879, NFI =.898, CFI =.969, IFI =.970, TLI =.959, RMR =.058. The results demonstrated that the data reasonably fitted the model. We also examined construct reliability and reliability and average variance extracted (AVE). The construct reliability of each construct was greater than.80 and the AVE of each construct was greater than.50. According to the analysis of Structure Equation Modeling (SEM), the results of path model indicated an adequate fit of the model: $X^2$= 142.126, p = 0.044, d.f. = 115, GFI =.892, NFI =.909, CFI =.981, IFI =.981, TLI =.974, RMR =.057. As hypothesized, the results showed that it is strategically important to establish trust in a franchise system, and the franchisor's supports, communication and satisfaction with previous outcome tend to reinforce franchisee's trust. The results also showed trust seems to decrease as the experience of conflict episodes increases. And we also noticed that franchisor's supports and communication tend to enhance the franchisee's satisfaction with previous outcome, and communication tend to decrease conflict. If the trust between the franchisor and franchisee can be established in a franchise system, franchising offers many benefits and reduces many costs. To manage a mutual trust of relationship with their franchisees, franchisor's should provide support effectively to their franchisees. Effective assistant services have direct effect on franchisees' satisfaction with previous outcome and trust in franchisor. Especially, franchise sales process, orientation, and training in the start-up period are key elements for success of the franchise system. Franchisor's support is an accumulated separate satisfaction evaluation with different kind of service provided by the franchisor. And providing support definitely can improve the trustworthy image of the franchisor. In the franchise system, conflicts of interests and exertions of different power sources are very common. The experience of conflict episodes seems to negatively relate to trust. Therefore, it is important to reduce the negative side of the relationship conflicts. Communication actually plays a broader role in reducing conflict and establish mutual trust in franchisor-franchisee relationship. And effective communication between franchisors and franchisees can improve franchisees' satisfaction toward the franchise system. As the diversification of Chinese markets, both franchisors and franchisees must keep the relevant, timely, and reliable communication. And it is very important to improve the quality of communication. Satisfaction with precious outcomes seems to positively relate to trust. Franchisors and franchisees that are highly satisfied with the previous outcomes that flow from their relationship will perceive their partner as advancing their goal achievement. Therefore, it is necessary for both franchisor and their franchisees to make the welfare of partner with effort. Little literature has focused on what factors affect the trust between franchisors and their franchisees in China. This study developed the hypotheses regarding the factors affecting trust in the transaction relationship. The results of data analysis supported the hypotheses strongly. There are certain limitations in this study. First, we may point out that some other factors missed in this study could be significantly important. Second, the context of this study, food service industry, limits its potential generalizability for all franchise systems. More studies in different categories of franchise system are needed to broaden its generalizability. Third, the model was tested empirically in a sample in Beijing, more empirical tests of the proposed model in other Chinese areas are needed. Finally, the analysis in this study was solely based on the perception of franchisees and the opinions of franchisors were not included.