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

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

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

BACKGROUND: The Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) block is a new anesthesiologist- administered analgesic technique for controlling posterior knee pain that has not yet been well studied in total knee arthroplasty (TKA) patients. We compared pain outcomes in TKA patients before and after implementation of the IPACK with the hypothesis that patients receiving IPACK blocks will report lower pain scores on postoperative day (POD) 0 than non-IPACK patients. METHODS: With Institutional Review Board approval, we retrospectively reviewed data for consecutive TKA patients by a single surgeon 4 months before (PRE) and after (POST) IPACK implementation. All TKA patients received adductor canal catheters and peri-operative multimodal analgesia. The primary outcome was pain on POD 0. Other outcomes were daily pain scores, opioid consumption, ambulation distance, length of stay, and adverse events within 30 days. RESULTS: Post-implementation, 48/50 (96%) of TKA patients received an IPACK block, and they were compared with 32 patients in the PRE group. On POD 0, the lowest pain score (median [10th–90th percentiles]) was significantly lower for the POST group compared to the PRE group (0 [0–4.3] vs. 2.5 [0–7]; P = 0.003). The highest patient-reported pain scores on any POD were similar between groups with no differences in other outcomes. CONCLUSIONS: Within a multimodal analgesic protocol, addition of IPACK blocks decreased the lowest pain scores on POD 0. Although other outcomes were unchanged, there may be a role for new opioid-sparing analgesic techniques, and changing clinical practice change can occur rapidly.
Analgesia ; Arthroplasty, Replacement, Knee ; Catheters ; Ethics Committees, Research ; Humans ; Knee ; Length of Stay ; Popliteal Artery ; Retrospective Studies ; Walking

Along with the advances in medical technology and the economic development, more terminally ill patients are receiving hospice and palliative care services. Moreover, hospice and palliative care clinicians have been showing considerable interest in studies that aim to improve the quality of said care for patients and their families. Meanwhile, after the government has strengthened its policy to protect research participants, the institutional review boards (IRBs) are more closely examining various ethical issues related to patients' vulnerability when reviewing protocols for hospice and palliative care research. However, terminally ill patients should be provided with guaranteed qualities of hospice and palliative care to improve and maintain their quality of life. To that end, support should be provided for efforts to conduct ethical and safe studies with hospice and palliative care patients. Thus, this review paper proposes ethical guidelines for hospice and palliative care research. The guidelines could be appropriately used as a reference for researchers who should prepare for ethically safe and scientifically valued research protocols and the IRBs that will review the protocols.
Economic Development ; Ethics ; Ethics Committees, Research ; Hospice Care ; Hospices ; Human Experimentation ; Humans ; Palliative Care ; Patient Rights ; Quality of Life ; Terminally Ill

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

OBJECTIVE: To compare the elasticity of the supraspinatus tendon (SST) and infraspinatus tendon (IST) in patients with idiopathic adhesive capsulitis of the shoulder (ACS) with those in the control groups and to evaluate the relationship between age and tendon elasticity. MATERIALS AND METHODS: The Institutional Review Board approved this prospective, case-control study, which was conducted between November 2017 and March 2018, and informed consent was obtained from all participants. Control groups comprised healthy individuals or those with asymptomatic contralateral shoulders. Twenty-five shoulders in 20 participants in the ACS group (14 women; 53.5 ± 7.9 years) and 24 shoulders in 18 participants in the control group (6 women; 52.6 ± 10.5 years) were included. Elastography was performed in the oblique coronal plane at the neutral shoulder position. Mean/maximum/minimum velocity and stiffness from the shear-wave ultrasound elastography (SWE) and strain ratio (subcutaneous fat/target-tendon) from the strain ultrasound elastography (SE) of the SST and IST were evaluated. Statistical analyses were performed using the Mann-Whitney U test, receiver operating characteristic (ROC) curve, and Spearman correlation. RESULTS: Both velocity and stiffness in SWE were higher, and the strain ratio in SE was lower in participants with symptomatic shoulders than in those with normal shoulders (p < 0.001). SST- and IST-mean velocity, mean stiffness, and strain ratios showed excellent area under the ROC curve (> 0.970). The elastic modulus was little correlated with age (ρ = −0.340–0.239). CONCLUSION: SWE and SE indicated that SST and IST were stiffer in patients with ACS than in those with normal shoulders regardless of aging.
Adhesives ; Aging ; Bursitis ; Case-Control Studies ; Elastic Modulus ; Elasticity ; Elasticity Imaging Techniques ; Ethics Committees, Research ; Female ; Humans ; Informed Consent ; Prospective Studies ; ROC Curve ; Rotator Cuff ; Shoulder ; Tendons ; Ultrasonography

OBJECTIVE: To develop algorithms using convolutional neural networks (CNNs) for automatic segmentation of acute ischemic lesions on diffusion-weighted imaging (DWI) and compare them with conventional algorithms, including a thresholding-based segmentation. MATERIALS AND METHODS: Between September 2005 and August 2015, 429 patients presenting with acute cerebral ischemia (training:validation:test set = 246:89:94) were retrospectively enrolled in this study, which was performed under Institutional Review Board approval. Ground truth segmentations for acute ischemic lesions on DWI were manually drawn under the consensus of two expert radiologists. CNN algorithms were developed using two-dimensional U-Net with squeeze-and-excitation blocks (U-Net) and a DenseNet with squeeze-and-excitation blocks (DenseNet) with squeeze-and-excitation operations for automatic segmentation of acute ischemic lesions on DWI. The CNN algorithms were compared with conventional algorithms based on DWI and the apparent diffusion coefficient (ADC) signal intensity. The performances of the algorithms were assessed using the Dice index with 5-fold cross-validation. The Dice indices were analyzed according to infarct volumes (< 10 mL, ≥ 10 mL), number of infarcts (≤ 5, 6–10, ≥ 11), and b-value of 1000 (b1000) signal intensities (< 50, 50–100, > 100), time intervals to DWI, and DWI protocols. RESULTS: The CNN algorithms were significantly superior to conventional algorithms (p < 0.001). Dice indices for the CNN algorithms were 0.85 for U-Net and DenseNet and 0.86 for an ensemble of U-Net and DenseNet, while the indices were 0.58 for ADC-b1000 and b1000-ADC and 0.52 for the commercial ADC algorithm. The Dice indices for small and large lesions, respectively, were 0.81 and 0.88 with U-Net, 0.80 and 0.88 with DenseNet, and 0.82 and 0.89 with the ensemble of U-Net and DenseNet. The CNN algorithms showed significant differences in Dice indices according to infarct volumes (p < 0.001). CONCLUSION: The CNN algorithm for automatic segmentation of acute ischemic lesions on DWI achieved Dice indices greater than or equal to 0.85 and showed superior performance to conventional algorithms.
Brain Ischemia ; Consensus ; Diffusion ; Ethics Committees, Research ; Humans ; Retrospective Studies

“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