1.Research ethics committees in Manila Schools: Exploring the reasons for its non-existence
Paulo Maria N. Pagkatipunan ; Elisa Bernadette E. Limson ; Anna Marie C. Abrera
Acta Medica Philippina 2022;56(13):12-19
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
2.Some Future-oriented Roles and Phases for the Ethics Committee of KMA.
Journal of the Korean Medical Association 2001;44(9):938-940
No abstract available.
Ethics Committees*
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Ethics*
3.Need for Clinical Trial Registry and Institutional Review Board Approval in Human Subjects Research.
Korean Journal of Family Medicine 2013;34(1):1-1
No abstract available.
Ethics Committees, Research
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Humans
4.Mandates pertaining to the ethical review of researches involving humans, and the establishment and accreditation of research ethics committees
Alvin S Concha ; Clarence Xlasi D Ladrero
Southern Philippines Medical Center Journal of Health Care Services 2021;7(1):1-3
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
5.The Suggestions for Improving the Institutional Review Board (IRB) in Clinical Trials: Focusing on Continuing Management.
Journal of Korean Society for Clinical Pharmacology and Therapeutics 2011;19(1):5-13
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
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Ethics, Research
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Humans
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Korea
6.Clinical trials and ethics.
Journal of the Korean Medical Association 2010;53(9):774-779
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
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Ethics Committees, Research
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Humans
7.Robotic extralevator excision of a retrorectal giant aggressive angiomyxoma.
Obstetrics & Gynecology Science 2018;61(6):693-697
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
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Myxoma*
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Robotics
8.End-of-Life planning among older Filipinos
Erryne Noelle C. Aguilar ; Mariah Stephanie L. Cardinal ; Jennifer D. Doria ; Casserine P. Dumpilo ; Christian Anthony C. Fabros ; Charlie Magne S. Flores ; Angelika Marie R. Milo ; Samantha Faye Q. Natino ; Angelo L. Ortiz ; Joyce Ann P. Pastor ; Vicente B. Turas III ; Raymund F. Mamayson ; Mary Rose D. Valenzuela
Philippine Journal of Nursing 2017;87(2):55-59
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
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Surveys and Questionnaires
9.Enactment of Code of Medical Ethics, KMA and Its Application.
Journal of the Korean Medical Association 2001;44(10):1065-1070
In May 2001, the Code of Medical Ethics, KMA was enacted by Korean Medical Association, but is not proclaimed yet. First of all, newly elected president of KMA should promulgate this code to the all members of the KMA and the public. The code would be used as the ext of the bio-medical ethics education for medical students and physicians as well as a concrete guideline for judgment by the independent ethics committees. And this code is due to be revised according to the change of socio-medical environment.
Education
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Ethics
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Ethics Committees
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Ethics, Medical*
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Humans
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Judgment
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Students, Medical
10.The Value of Additional Cervicothoracic Spine Sagittal T2-weighted Images Included in Routine Lumbar Spine MR Imaging.
Jiwoon SEO ; So Young PARK ; Joon Woo LEE ; Guen Young LEE ; Heung Sik KANG
Journal of the Korean Society of Magnetic Resonance in Medicine 2013;17(2):91-100
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
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Humans
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Retrospective Studies
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Spine