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: Sickle cell anemia (SCA) is a hereditary chronic hemolytic anemia with several clinical consequences. Intravascular sickling of red blood cells leads to multi-organ dysfunction. Moreover, several biochemical abnormalities have been associated with SCA. Gum arabic (GA) is an edible dried gummy exudate obtained from Acacia Senegal tree. GA showed antioxidant and cytoprotective activities and demonstrated protection against hepatic, renal, and cardiac toxicities in experimental rats. We hypothesized that regular intake of GA improves renal and liver functions in patients with SCA. METHODS: Forty-seven patients (5–42 yr) carrying hemoglobin SS were recruited. The patients received 30 g/day GA for 12 weeks. Blood samples were collected before administering GA and then after 4, 8, and 12 weeks. Liver enzymes, total protein, albumin, electrolytes, urea, creatinine, and uric acid were determined in the serum. The study was approved by the Al Neelain University Institutional Review Board and Research Ethics Committee Ministry of Health. The trial was registered at ClinicalTrials.gov (identifier: NCT02467257). RESULTS: GA significantly decreased direct bilirubin level [statistical significance (P-value)=0.04]. It also significantly decreased serum alanine transaminase level after 4 weeks, which was sustained till the 8th week. GA, however, had no effect on serum aspartate transaminase level. In terms of renal function, GA decreased serum urea level but the effect was not sustained after the first month. CONCLUSION: GA may alter the disease severity in SCA as demonstrated by its ability to decrease direct bilirubin and urea levels in the serum.
Acacia ; Alanine Transaminase ; Anemia, Hemolytic ; Anemia, Sickle Cell ; Animals ; Aspartate Aminotransferases ; Bilirubin ; Cardiotoxicity ; Creatinine ; Electrolytes ; Erythrocytes ; Ethics Committees, Research ; Exudates and Transudates ; Gingiva ; Gum Arabic ; Hemoglobin, Sickle ; Humans ; Liver ; Rats ; Senegal ; Trees ; Urea ; Uric Acid

OBJECTIVE: To analyze the complications of percutaneous transthoracic needle biopsy using CT-based imaging modalities for needle guidance in comparison with fluoroscopy in a large retrospective cohort. MATERIALS AND METHODS: This study was approved by multiple Institutional Review Boards and the requirement for informed consent was waived. We retrospectively included 10568 biopsies from eight referral hospitals from 2010 through 2014. In univariate and multivariate logistic analyses, 3 CT-based guidance modalities (CT, CT fluoroscopy, and cone-beam CT) were compared with fluoroscopy in terms of the risk of pneumothorax, pneumothorax requiring chest tube insertion, and hemoptysis, with adjustment for other risk factors. RESULTS: Pneumothorax occurred in 2298 of the 10568 biopsies (21.7%). Tube insertion was required after 316 biopsies (3.0%), and hemoptysis occurred in 550 cases (5.2%). In the multivariate analysis, pneumothorax was more frequently detected with CT {odds ratio (OR), 2.752 (95% confidence interval [CI], 2.325–3.258), p < 0.001}, CT fluoroscopy (OR, 1.440 [95% CI, 1.176–1.762], p < 0.001), and cone-beam CT (OR, 2.906 [95% CI, 2.235–3.779], p < 0.001), but no significant relationship was found for pneumothorax requiring chest tube insertion (p = 0.497, p = 0.222, and p = 0.216, respectively). The incidence of hemoptysis was significantly lower under CT (OR, 0.348 [95% CI, 0.247–0.491], p < 0.001), CT fluoroscopy (OR, 0.594 [95% CI, 0.419–0.843], p = 0.004), and cone-beam CT (OR, 0.479 [95% CI, 0.317–0.724], p < 0.001) guidance. CONCLUSION: Hemoptysis occurred less frequently with CT-based guidance modalities in comparison with fluoroscopy. Although pneumothorax requiring chest tube insertion showed a similar incidence, pneumothorax was more frequently detected using CT-based guidance modalities.
Biopsy ; Biopsy, Needle ; Chest Tubes ; Cohort Studies ; Cone-Beam Computed Tomography ; Ethics Committees, Research ; Fluoroscopy ; Hemoptysis ; Image-Guided Biopsy ; Incidence ; Informed Consent ; Lung Neoplasms ; Multivariate Analysis ; Needles ; Pneumothorax ; Referral and Consultation ; Retrospective Studies ; Risk Factors

OBJECTIVE: The aim of our study was to develop and validate a convolutional neural network (CNN) architecture to convert CT images reconstructed with one kernel to images with different reconstruction kernels without using a sinogram. MATERIALS AND METHODS: This retrospective study was approved by the Institutional Review Board. Ten chest CT scans were performed and reconstructed with the B10f, B30f, B50f, and B70f kernels. The dataset was divided into six, two, and two examinations for training, validation, and testing, respectively. We constructed a CNN architecture consisting of six convolutional layers, each with a 3 × 3 kernel with 64 filter banks. Quantitative performance was evaluated using root mean square error (RMSE) values. To validate clinical use, image conversion was conducted on 30 additional chest CT scans reconstructed with the B30f and B50f kernels. The influence of image conversion on emphysema quantification was assessed with Bland–Altman plots. RESULTS: Our scheme rapidly generated conversion results at the rate of 0.065 s/slice. Substantial reduction in RMSE was observed in the converted images in comparison with the original images with different kernels (mean reduction, 65.7%; range, 29.5–82.2%). The mean emphysema indices for B30f, B50f, converted B30f, and converted B50f were 5.4 ± 7.2%, 15.3 ± 7.2%, 5.9 ± 7.3%, and 16.8 ± 7.5%, respectively. The 95% limits of agreement between B30f and other kernels (B50f and converted B30f) ranged from −14.1% to −2.6% (mean, −8.3%) and −2.3% to 0.7% (mean, −0.8%), respectively. CONCLUSION: CNN-based CT kernel conversion shows adequate performance with high accuracy and speed, indicating its potential clinical use.
Dataset ; Emphysema ; Ethics Committees, Research ; Image Processing, Computer-Assisted ; Machine Learning ; Multidetector Computed Tomography ; Retrospective Studies ; Tomography, X-Ray Computed

OBJECTIVE: According to the current guidelines, arterial hyperenhancement for diagnosis of hepatocellular carcinoma (HCC) is determined using the arterial phase only. We investigated the optimal definition of arterial hyperenhancement in patients with HCC using computed tomography (CT) and magnetic resonance imaging (MRI). MATERIALS AND METHODS: The Institutional Review Board approved this retrospective study. The requirement for informed consent was waived. Between January 2011 and September 2013, 147 consecutive patients with surgically proven HCCs with both pre-operative CT and MRI were included. Identification rates of arterial hyperenhancement on CT and magnetic resonance (MR) images using arterial phase only, dual phase (unenhanced and arterial phases), and also subtraction MR images were assessed qualitatively. RESULTS: The identification rates for arterial hyperenhancement on CT were significantly different between arterial phase and dual phase (72.8% vs. 90.5%; p < 0.001), whereas the rates were similar on MRI (91.8% vs. 93.9%; p = 0.257). The identification rate of arterial hyperenhancement in MRI increased to 98.6% using subtraction MR images. CONCLUSION: Visual comparison of arterial and unenhanced phases could be recommended instead of conventional qualitative arterial phase alone assessment to determine arterial hyperenhancement of HCCs, especially when using CT.
Carcinoma, Hepatocellular ; Diagnosis ; Ethics Committees, Research ; Humans ; Informed Consent ; Magnetic Resonance Imaging ; Retrospective Studies

OBJECTIVE: To assess whether virtual expiratory (VE)-computed tomography (CT)/ultrasound (US) fusion imaging is more effective than conventional inspiratory (CI)-CT/US fusion imaging for hepatic interventional procedures. MATERIALS AND METHODS: This prospective study was approved by the Institutional Review Board, and informed consent was obtained from each patient. In total, 62 patients with focal hepatic lesions referred for hepatic interventional procedures were enrolled. VE-CT images were generated from CI-CT images to reduce the effects of respiration-induced liver motion. The two types of CT images were fused with real-time US images for each patient. The operators scored the visual similarity with the liver anatomy upon initial image fusion and the summative usability of complete image fusion using the respective five-point scales. The time required for complete image fusion and the number of point locks used were also compared. RESULTS: In comparison with CI-CT/US fusion imaging, VE-CT/US fusion imaging showed significantly higher visual similarity with the liver anatomy on the initial image fusion (mean score, 3.9 vs. 1.7; p < 0.001) and higher summative usability for complete image fusion (mean score, 4.0 vs. 1.9; p < 0.001). The required time (mean, 11.1 seconds vs. 22.5 seconds; p < 0.001) and the number of point locks (mean, 1.6 vs. 3.0; p < 0.001) needed for complete image fusion using VE-CT/US fusion imaging were significantly lower than those needed for CI-CT/US fusion imaging. CONCLUSION: VE-CT/US fusion imaging is more effective than CI-CT/US fusion imaging for hepatic interventional procedures.
Ethics Committees, Research ; Humans ; Informed Consent ; Liver ; Prospective Studies ; Respiration ; Ultrasonography ; Weights and Measures