Objectives: This study aimed to explore the reasons behind the “resistance” of higher education institutions (HEIs) located in the south Manila area in creating research ethics committees (RECs). It also examined the proportion of researches in these HEIs with human participation. Methods: Research directors underwent key informant interviews while faculty researchers participated in focus group discussions. Universal sampling was employed on all researches in the schools to determine the proportion with human participants and to know if they are ethically “high risk“ or “low risk” in terms of the participants’ involvement. Results: We included ten higher education institutions in this study. Research directors and faculty researchers agreed that their school should have a REC and that studies should undergo ethical evaluation before commencement of data collection. Half of all researches were found to have human participant involvement and, after developing a tool to determine the risk level to participants, this study found that ethically high risk researches are found to represent 10% as a proportion of the total researches done in the schools. Conclusion Almost all respondents in this study agreed that RECs should be created; however, there are financial challenges that schools face in establishing RECs.
Ethics Committees

In 2003, the secretaries of the Department of Health (DOH) and the Department of Science and Technology (DOST) signed a memorandum of understanding to institutionalize the Philippine National Health Research System (PNHRS) for the management of research in the country.1 One of the groups constituted under the PNHRS was the Technical Working Group (TWG) on Ethics, which created strategies that highlight the role of ethics in a responsible health research system. Among the recommendations of the Ethics TWG was the establishment of the Philippine Health Research Ethics Board (PHREB).2 In 2006, the PHREB was formally created through DOST Special Order 2006-91 “to ensure that all phases of health research shall adhere to universal ethical principles that value the protection and promotion of the dignity of health research participants.” Since then, PHREB has become the country’s policy making body on health research ethics.2 3 In 2013, the Republic Act 10532一or the PNHRS Law一was enacted.4 The Act strengthened the mandate of PHREB to ensure protection of the welfare, rights, and safety of human research participants, and the implementing rules and regulations (IRR) of the Act specified the policies that facilitate the achievement of the PHREB mandate.5 In 2017, through DOST Special Order 2017-248, DOST established research ethics monitoring boards (REMBs) in Region I, Region VI, and Region XI to assist in the comprehensive and consistent implementation of PHREB policies at the regional level.6 The creation of PHREB in 2006 initiated several other mandates from PHREB and other agencies that implement the PNHRS. These mandates一shown in the infographic一support human research participant protection through ethical reviews of research protocols, establishment of research ethics committees, and maintenance of quality standards of these committees through accreditation. Many of these mandates are national in scope, but a few are specific to Davao Region (Region XI).
Ethics Committees, Research

Aspergillosis ; Ethics Committees, Research ; Fungi ; Humans ; Korea ; Magnetic Resonance Imaging ; Mycetoma ; Paranasal Sinuses ; Retrospective Studies ; Sinusitis

OBJECTIVES: This study investigates the current state of consuming breakfast among elementary school students residing in Malang, East Java, Indonesia, and to identify factors that influence breakfast behavior.METHODS: The research model was set up as per the health belief model, and slightly modified by adding the subjective normative factors of the theory of planned behavior. The survey was conducted from July 17 to August 15, 2017 using a questionnaire, after receiving the permission PNU IRB (2017_60_HR).RESULTS: The subjects were 77 boys (49.4%) and 79 girls (50.6%) suffering from malnutrition with anemia (21.2%) and stunting ratio of Height for Age Z Score (HAZ) (11.5%). Furthermore, moderate weakness (14.8%) and overweight and obesity (12.3%) by Body Mass Index for Age Z Score (BMIZ) were coexistent. According to the results obtained for breakfast, 21.8% did not eat breakfast before school, with 18.8% of the reasons for skipping breakfast being attributed to lack of food. Even for subjects partaking breakfast, only about 10% had a good balanced diet. The average score of behavioral intention on eating breakfast was 2.60 ± 0.58. The perceived sensitivity, perceived severity, perceived benefits, and self-efficacy of the health belief model correlated with breakfast behavior. Of these, self-efficacy (β=0.447, R²=0.200) and perceived sensitivity (β=0.373, R²=0.139) had the greatest effect on breakfast behavior. Mother was the largest impact person among children.CONCLUSIONS: In order to increase the level of breakfast behavior intention among children surveyed in Indonesia, we determined the effectiveness by focus on education which helps the children recognize to be more likely to get sick when they don't have breakfast, and increase their confidence in ability to have breakfast on their own. We believe there is a necessity to seek ways to provide indirect intervention through mothers, as well as impart direct nutrition education to children.
Anemia ; Body Mass Index ; Breakfast ; Child ; Diet ; Eating ; Education ; Ethics Committees, Research ; Female ; Growth Disorders ; Humans ; Indonesia ; Intention ; Malnutrition ; Mothers ; Obesity ; Overweight

“This study was reviewed and approved by the Institutional Review Board (IRB approval no., 2019-02-095) and informed consent was waived” is to be added at the end of methods section.
Coronary Artery Bypass ; Coronary Vessels ; Ethics Committees, Research ; Informed Consent ; Transplants ; Ventricular Dysfunction, Left

Ameloblastoma in the tibia is rare. Limb reconstruction after tumor resection is challenging in terms of selection of the operative method. Here, we report a case of radical resection of an ameloblastoma in the mid-distal tibia combined with limb salvage using a three-dimensional (3D)-printed prosthesis replacement, with 1-year follow-up results. After receiving local institutional review board approval, a titanium alloy prosthesis was designed using a computer and manufactured with 3D-printing technology. During the operation, the stem of the prosthesis was inserted closely into the proximal tibial medullary cavity. Then, the metal ankle mortise and the talus were compacted closely. Radiographic results at 1-year follow up showed that the prosthesis was well placed, and no loosening was observed. The Musculoskeletal Tumor Society (MSTS) 93 functional score was 26 points, and the functional recovery percentage was 86.7%. Computer-assisted 3D-printing technology allowed for more volume and structural compatibility of the prosthesis, thereby ensuring a smooth operation and initial prosthetic stabilization. During the follow up, the presence of bone ingrowths on the porous surface of some segments of the prosthesis suggested good outcomes for long-term biological integration between the prosthesis and host bone.
Alloys ; Ameloblastoma ; Ankle ; Ethics Committees, Research ; Extremities ; Follow-Up Studies ; Limb Salvage ; Methods ; Prostheses and Implants ; Talus ; Tibia ; Titanium

BACKGROUND: The detection rate of hand-arm vibration syndrome (HAVS) is very low in South Korea compared with other countries. The absence of uniform consensus and guidelines for diagnosing HAVS has been presumed to be one of the reasons. The HAVS has various manifestations including cold intolerance and its severity can be measured using the cold intolerance symptom severity (CISS) questionnaire. This study aimed to determine whether the CISS questionnaire, being used as a screening tool, can aid in the early detection of HAVS. METHODS: A total of 76 male workers with vibration-induced symptoms were enrolled as the final study participants. To compare the CISS score of healthy individuals, 41 men who had never been exposed to local vibration were included in the study. In addition to the former medical questionnaire, the participants answered the CISS questionnaire. A statistical analysis was conducted to identify the association of CISS scores with vibration induced symptom and to determine its cut off value. RESULTS: The reliability of the CISS questionnaire was proven to be good, with a total Cronbach's alpha of 0.922. The mean CISS score of the exposed group increased in every vascular stage [stage 0 = 42.6 (18.5); stage 1 = 59.4 (14.1); and over stage 2 = 60.2 (21.6)]. They were significantly higher than that of the non-exposed group. The result was fairly consistent with those in the sensorineural stage. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under curve (AUC) of 30 were 88.5, 65.3, 76.1, 82.1 and 0.769, respectively. From the result of logistic regression, the adjusted odds ratio of both components increased by the CISS score grouped by 30s. CONCLUSIONS: The self-reported CISS questionnaire, used to measure the degree of cold intolerance, showed high agreement with the Stockholm classification of HAVS. Hence, we recommend the use of this questionnaire to assess the level of cold intolerance among vibration-exposed workers and detect individuals who are at risk of vibration-induced impairment with a cutoff value of 30. TRIAL REGISTRATION: IRB No. 2018–07–040-001. Registered on 4 September 2018.
Area Under Curve ; Classification ; Clothing ; Consensus ; Cross-Sectional Studies ; Ethics Committees, Research ; Hand-Arm Vibration Syndrome ; Humans ; Korea ; Logistic Models ; Male ; Mass Screening ; Odds Ratio ; Sensitivity and Specificity ; Vibration

PURPOSE: A cross-sectional survey was conducted to explore the current awareness and use of complementary and alternative medicine (CAM), as well as attitudes toward CAM, in patients with cancer and their family members in South Korea. MATERIALS AND METHODS: Between September 21 and October 31, 2017, a 25-item questionnaire regarding CAM experiences among cancer patients and their family members was conducted in 10 oncology clinics in South Korea after institutional review board approval at each institution. RESULTS: In total, 283/310 patients were analyzed. The median age was 60 years, and 60% were male. Most of the patients were actively receiving anticancer treatment at the time of the survey. A total of 106 patients (37%) had experienced a median of two types (interquartile range, 1 to 3) of CAM. Belief in CAM (odds ratio [OR], 3.015; 95% confidence interval [CI], 1.611 to 5.640) and duration of disease (OR, 1.012; 95% CI, 1.004 to 1.020) were independent factors for using CAM in multivariable analysis. Belief in CAM was significantly associated with current use of CAM (OR, 3.633; 95% CI, 1.567 to 8.424). Lay referral was the most common reason for deciding to use CAM, and only 25% of patients (72/283) discussed CAM with their physicians. CONCLUSION: Patient attitudes toward and confidence in CAM modalities were strongly associated with their CAM experiences, and only a small number of patients had an open discussion about CAM with their physicians. A patient education program for CAM is needed.
Complementary Therapies ; Cross-Sectional Studies ; Ethics Committees, Research ; Humans ; Korea ; Male ; Patient Education as Topic ; Referral and Consultation

BACKGROUND: This study aimed to provide basic data to establish a foundation for efficient operation of the organization by assessing the effects of self-efficacy and job stress (measured by self-efficacy, job demand, and job autonomy) on organizational commitment among clinical dental hygienists. METHODS: This was a cross-sectional survey study that used a self-administered questionnaire to collect data. After institutional review board approval, a survey was conducted from January to May 2017, targeting dental hygienists working in dental clinics and hospitals. The final 199 questionnaires were analyzed with PASW 18.0 for Windows (IBM Corp.). The data were analyzed using mean and/or standard deviation t-test, one-way ANOVA, and multiple regression analysis. RESULTS: The means for self-efficacy, job demand, job autonomy, and organizational commitment were 55.94±9.65, 26.55±2.29, 20.24±3.88, and 49.49±8.39, respectively. Along with self-efficacy, the other factors of organizational commitment among dental hygienists that were statistically significant included job autonomy, mean salary (2,500~2,990 thousand Korean won [KRW] and ≥3,000 thousand KRW), and employee welfare (good), which are sub-areas of the surface acting. In other words, it was found that the higher the mean salary, the better the employee welfare, the higher self-efficacy, and the higher the organizational commitment, and the explanatory power of the model was approximately 42.1%. CONCLUSION: These results suggest that the higher the self-efficacy, job autonomy, mean salary, and employee welfare, the higher the organizational commitment. In order to improve job demand among dental hygienists, it is necessary to establish an effective plan to improve job welfare, self-efficacy, and job autonomy.
Cross-Sectional Studies ; Dental Clinics ; Dental Hygienists ; Ethics Committees, Research ; Humans ; Salaries and Fringe Benefits

OBJECTIVE: To identify factors associated with non-completion of intraperitoneal with intravenous chemotherapy [IP/IV] in women with epithelial ovarian cancer (EOC). METHODS: This was an Institutional Review Board approved, retrospective cohort study in women with stage III EOC following optimal cytoreductive surgery (CRS) (<1 cm) followed by IP/IV chemotherapy from 2000–2016. Demographic, surgical, and oncologic variables were collected. Pearson χ2 test and 2 sample t-test evaluated for variables associated with IP/IV chemotherapy completion. Kaplan-Meier survival analysis was performed for progression-free survival (PFS) and overall survival (OS). RESULTS: Of 96 women, 71.9% (n=69) completed 6 cycles of IP/IV chemotherapy. The majority had high grade serous histology (n=82; 85.4%) and stage IIIC disease (n=83; 86.5%). Common reasons for IP/IV chemotherapy discontinuation were grade 3–4 gastrointestinal (n=10; 37.0%), neurologic (n=6; 22.2%), hematologic (n=3; 11.1%), renal toxicities (n=3; 11.1%) and port infections (n=3; 11.1%). Incidence of IP port complications was 20.8% (n=20). Port complications (48.0% vs. 11.6%; p<0.001) and hospitalization during chemotherapy (29.6% vs. 2.9%; p<0.001) were more frequent in patients who discontinued IP/IV chemotherapy. Patients who completed IP/IV chemotherapy had higher rates of home discharge following CRS (92.2% vs. 72.0%; p<0.01) and lower Eastern Cooperative Oncology Group (ECOG) score (0 vs. 1.0; p=0.04). There was no significant difference in PFS (p=0.51) nor OS (p=0.38) between the cohorts. CONCLUSION: In this series, the rate of IP/IV chemotherapy completion is high. Non-home discharge and higher ECOG status following CRS are associated with IP/IV chemotherapy non-completion and should be considered in treatment planning.
Chemotherapy, Adjuvant ; Cohort Studies ; Disease-Free Survival ; Drug Therapy ; Ethics Committees, Research ; Female ; Hospitalization ; Humans ; Incidence ; Infusions, Parenteral ; Ovarian Neoplasms ; Retrospective Studies