As more research work is done on eye disorders, more safety rules and regulations are required to ensure the safety of trial subjects. This is the main function of Research Ethics Committees [also known as Institutional Review Boards (IRBs) and Domain Specific Review Boards (DSRBs)]. Tragedies in research in other fields are wake-up calls, such as the death of a healthy young volunteer subject in New York, the termination of a large study sparked by breach of medical confidentiality in Singapore and the South Korean debacle of its pioneering work in cloning. Many issues are still being debated, such as what statutory changes are required to control trials; whether all trials should be reviewed by IRB; if phase IV trials should be exempted; if compensation should be paid for all trial-related injuries; and whether investigators and IRB members be allowed to hold certain amount of shares in drug or device firms. Recent measures taken to prevent ethical problems include funding organisations not approving a study unless it has been cleared by the IRB, and requiring all investigators and IRB members to pass an ethics course. More measures will need to be taken to ensure the safety of the trial subjects involved in research studies.
Clinical Trials as Topic ; ethics ; Conflict of Interest ; Ethics Committees, Research ; Ethics, Research ; Humans ; Ophthalmology ; Singapore

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

PURPOSE: The objective of this study is to analyze systematically the trends of experimental researches in the area of community health nursing. METHODS: This is a study based on literature review, which analyzed 137 experimental research papers in the Journal of Korean Academy of Community Health Nursing, from the first issue in 1989 to those in 2012. RESULTS: 1) The proportion of experimental researches in the total published papers was 14.9%. 2) The mainly used research method was quasi-experiment, which was 60.6% of them, and there was no RCT. 3) Convenient sampling was used in 95.6% of the researches. 4) Only 5.1% were reviewed for keeping the ethical standards for the study objects by the IRB. 5 When classified by the Omaha Classification System, psycho-social researches were most frequent, which were followed by physiological, health-related behavioral, and environmental ones in order of frequency. CONCLUSION: This study found that the proportion of experimental research papers was increasing in the 2000s and ethical standards were required more rigorously. However, it was suggested that the research design be more elaborated and sampling methods be manifested to reduce research bias and errors.
Bias (Epidemiology) ; Classification ; Community Health Nursing* ; Ethics Committees, Research ; Clinical Trial ; Research Design

OBJECTIVE: To assess whether contrast-enhanced ultrasonography (CEUS) with Sonazoid can improve the lesion conspicuity and feasibility of percutaneous biopsies for focal hepatic lesions invisible on fusion imaging of real-time ultrasonography (US) with computed tomography/magnetic resonance images, and evaluate its impact on clinical decision making. MATERIALS AND METHODS: The Institutional Review Board approved this retrospective study. Between June 2013 and January 2015, 711 US-guided percutaneous biopsies were performed for focal hepatic lesions. Biopsies were performed using CEUS for guidance if lesions were invisible on fusion imaging. We retrospectively evaluated the number of target lesions initially invisible on fusion imaging that became visible after applying CEUS, using a 4-point scale. Technical success rates of biopsies were evaluated based on histopathological results. In addition, the occurrence of changes in clinical decision making was assessed. RESULTS: Among 711 patients, 16 patients (2.3%) were included in the study. The median size of target lesions was 1.1 cm (range, 0.5–1.9 cm) in pre-procedural imaging. After CEUS, 15 of 16 (93.8%) focal hepatic lesions were visualized. The conspicuity score was significantly increased after adding CEUS, as compared to that on fusion imaging (p < 0.001). The technical success rate of biopsy was 87.6% (14/16). After biopsy, there were changes in clinical decision making for 11 of 16 patients (68.8%). CONCLUSION: The addition of CEUS could improve the conspicuity of focal hepatic lesions invisible on fusion imaging. This dual guidance using CEUS and fusion imaging may affect patient management via changes in clinical decision-making.
Biopsy* ; Clinical Decision-Making ; Ethics Committees, Research ; Humans ; Liver ; Retrospective Studies ; Ultrasonography*

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

The institutional review board is crucial to ensure the scientific and ethical quality of human participant research. This paper analyzes a survey on the current constitution and operation of institutional review boards (IRBs) in Korea, conducted by the Korean Association of Institutional Review Boards in April 2002. Out of 74 IRBs, 63 responded to the survey (85.1% response rate). IRB membership has a male-to-female ratio of approximately 80:20, a predominance of male clinicians (60%) and an underrepresentation of community people unaffiliated to the institutions (less than 10%). Most IRBs (around 80%) confine the scope of their reviews to the clinical evaluation of drugs or devices, leaving the remaining areas of research involving human participants untouched. As their role is limited, the majority of IRBs do not operate actively: 72% of responding IRBs reviewed less than one protocol per month in 2001. Sixty two percent of institutions have never discussed the need for insuring research participants' risks or making indemnity arrangements. This survey reveals many shortcomings and points for improvement by the institutional support bodies, including the need to establish regular education programs for IRB members and investigators.
Appointments and Schedules ; Clinical Trials/legislation & jurisprudence ; Clinical Trials/standards ; Data Collection ; Epidemiologic Studies ; Ethics Committees, Research*/legislation & jurisprudence ; Ethics Committees, Research*/standards ; Ethics Committees, Research*/statistics & numerical data ; Female ; Human ; Human Experimentation/legislation & jurisprudence ; Human Experimentation/standards ; Korea ; Male ; Politics ; Public Policy ; Research Design/standards