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

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

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: 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

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