No abstract available.
Ethics Committees, Research ; Humans

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

As Korea has increasing number of clinical trials in recent years, institutional review boards (IRBs) are facing new challenges. The IRB should review submitted documents and supervise clinical trials from the beginning to the end to protect human subjects. Although most IRBs invest much time and efforts to initial review, they rarely conduct proper continuing management at the moment. The purpose of this article is to describe challenges involving continuing management, which includes unanticipated problems, subject's complaints, site visit, and continuing review, and to provide suggestions for improving it. Above all, institutions should perceive the importance of continuing management and they should provide sufficient manpower and resources for the management.
Ethics Committees, Research ; Ethics, Research ; Humans ; Korea

Based on recently developed biotechnology, many new drugs have been developed for improving patient treatment outcomes. To develop novel drugs, proper clinical trials are essential. As clinical trials involve humans in research, the protection of participants is important not only for the participants' safety but also for future patients. Ethics in a clinical trial is not the same as in clinical practice with enough evidence. Hence, the whole procedure of a clinical trial should be well organized, scientifically and ethically planned, and monitored properly by an Institutional Review Board (IRB). Here the importance of ethics in clinical trials, related issues, and the monitoring system will be discussed.
Biotechnology ; Ethics Committees, Research ; Humans

Aggressive angiomyxoma (AA) is a very rare mesenchymal tumor most commonly found in the pelvic and perineal regions. For the complete excision of retrorectal tumors, with extension through the levator muscle into the ischioanal space, open anterior and posterior approaches are typically required. Herein, we report our experience with robotic excision of a giant presacral AA with extralevator extension into the ischioanal space and extraction via Pfannenstiel incision, which we found to be technically feasible, efficacious, and safe to perform. Mayo Clinic Institutional Review Board exemption status was obtained for this study.
Ethics Committees, Research ; Myxoma* ; Robotics

Purpose: The number of older Filipinos continues to rise resulting in increasing numbers of people who live in a modernized world which offers numerous options to prepare for the End-of-Life (EoL). Henceforth, EoLplanning among older Filipinos and the factors which could potentially influence the propensity to plan ahead needs further investigation. This study ascertained the level of health, relationship, funerary, legal and financial-related EoL planning among older Filipinos, and established the association between EoL planning and sex, chronologic age, religious affiliation, ethnicity, health and financial status. Methods: The study utilized a descriptive survey design, including 400 respondents, chosen through purposive sampling and met the inclusion of Filipino, Baguio residents, aged 60 and above, able to read and understand English, Filipino or Ilokano, and without psychological disturbances or cognitive deficits. The researchers used a self-made questionnaire after establishing validity (0.96) and reliability (0.82). The Saint Louis University Research Ethics Committee ensured the ethical conduct of this research. Data were treated with statistics using frequency, mean and Chi-square test. Findings: The responses indicated moderate levels of EoL planning overall. Moreover, statistical tests revealed that only health status has a significant association with EoLplanning. Conclusions Based on the findings, the researchers conclude that EoL planning remains not widely used in the Philippines, thus, intensifying the call for more aggressive interventions to make EoL planning salient and acceptable to older people. In addition, health status affects EoL planning considerably, and that knowing the sex, chronologic age, religious affiliation, ethnicity and financial status did not help predict EoLplanning.
Ethics Committees, Research ; Surveys and Questionnaires

BACKGOUND: All medical research requires approval of the institutional review board ( IRB ) and informed consent from the research participants in advance. But there are reports of low rates of IRB approval in major anesthesia journals. The purpose of the study is to investigate IRB approval and informed consent rates of Korean anesthetic field researches and provide suggestion. METHODS: We reviewed 11 years data from Korean journal of anesthesiology and obtained the number and percentage of IRB approved papers, informed consents and verbal consents. RESULTS: The total number and percentage of IRB approved papers has increased to 60% and so as cases with informed consents over the past 11 years. But the ratio is still under 25%. The ratio of informed consent against verbal consent is also increasing. CONCLUSIONS: The number of IRB approved and informed consented papers have increased. But the proportion is still not satisfying or low. Changes in understandings of the clinical researchers with education of research ethics and systemic establishment are needed.
Anesthesia ; Anesthesiology ; Education ; Ethics Committees, Research* ; Ethics, Research ; Informed Consent*

While Korea does not have any legal statement on surrogacy, treatments are carried out in practice. As a result, every Institutional Review Board (IRB) of each fertility clinic faces an ethical predicament in reviewing each case. There is a need to arrange the institutions' own standards of surrogate pregnancy procedures before the establishment of national or professional regulation. This article examines the legal, social, and medical issues of surrogacy to help IRBs to judge their cases.
Ethics Committees, Research ; Fertility ; Korea ; Pregnancy

BACKGROUND: Because low quality trials may lead to wrong conclusions, quality assessments are necessary. Thus, this study scrutinizes randomized controlled trials (RCTs) in the Journal of the Korean Academy of Family Medicine (KAFM) to assess the quantity and the quality. METHODS: Upon extracting randomized controlled trials from all the articles published in the Journal of the KAFM from 1980 to 2005, assessments were made on the Jadad scale and the adequacy of allocation concealment. The selections and assessments were performed independently by two researchers, and adjustment of the differences were done by a third-party researcher. In addition, the factors that may affect the quality levels were analyzed. RESULTS: Twenty-three trials were included. In 1980s, there were only 1.09% of the total original articles, but in 2000s, 2.63% were RCTs. The mean total Jadad score increased from 1 point in 1980s to 2.17 in 2000s, and the "good quality" trials also increased from 0% to 33.33%. As for the adequate allocation concealment, however, only two studies were observed in 2000s. The most lacking aspect was the appropriate double-blinding. Also, studies intervened by medicine or funded or examined by Institutional Review Boards (IRBs) tended to receive higher quality assessments. CONCLUSION: Although RCTs consistently increased in quantity and quality, in future studies, researchers should continue to strive towards achieving adequate allocation concealment and appropriate double-blinding. In addition, researchers must become more interested in receiving funds and examination by IRBs.
Ethics Committees, Research ; Financial Management ; Humans

PURPOSE: To evaluate the usefulness of cervicothoracic spine sagittal T2-weighted images (CT SAG T2WIs) included in routine lumbar spine MRI. MATERIALS AND METHODS: Institutional review board approval was obtained and informed consents were waived for this retrospective study. The study group comprised 2,113 patients who underwent lumbar spine MRI from January 2005 to December 2005. CT SAG T2WIs were added in the routine lumbar spine MRIs. Radiologic reports were reviewed retrospectively for pathologic lesions on CT SAG T2WIs by one radiologist. Information of additional cervical or thoracic spine MRI and/or CT for further evaluation of positive findings on CT SAG T2WIs and their treatment were collected by retrospectively reviewing medical records. RESULTS: The CT SAG T2WIs revealed 142 pathologic lesions in 139 (6.58%) of the 2,113 patients. They were easily obtained without positional change in a scan time of less than 2 minutes. Additional cervical or thoracic spine MRI and/or CT for positive findings on CT SAG T2WIs were performed in 13 patients. Seven patients underwent surgical treatment. CONCLUSION: CT SAG T2WIs included in routine lumbar spine MRI were useful in finding the pathologic lesions in cervicothoracic spine for the patients who assumed to have lesions in lumbar spine.
Ethics Committees, Research ; Humans ; Retrospective Studies ; Spine