Attitude of Health Personnel ; Biomedical Research ; Child ; Ethics, Research ; Humans ; Pediatrics

No abstract available.
Humans ; Journal Impact Factor ; Publishing/ethics/*standards ; Research ; Research Personnel/ethics

No abstract available.
Humans ; Peer Review, Research/*ethics ; Periodicals as Topic ; Publishing/*ethics ; Research Personnel

An institutional review board (IRB) should independently safeguard the right, safety, and well-being of all clinical trial subjects. It should consist of members who are qualified and experienced to review and evaluate the science, medical aspects, and ethics of the proposed trial. They have to pursue continuing efforts to improve the standards of review. The levels of review include the full board review, expedited review, continuing review, or exempt from review, while the levels of decision-making include approval, conditional approval, deferred approval, and disapproval. Investigators must follow the approved protocols and regulations honestly, and it is the IRB's mission to audit clinical trial sites as well.
Ethics ; Ethics Committees, Research* ; Humans ; Missions and Missionaries* ; Research Personnel ; Social Control, Formal

An institutional review board (IRB) should independently safeguard the right, safety, and well-being of all clinical trial subjects. It should consist of members who are qualified and experienced to review and evaluate the science, medical aspects, and ethics of the proposed trial. They have to pursue continuing efforts to improve the standards of review. The levels of review include the full board review, expedited review, continuing review, or exempt from review, while the levels of decision-making include approval, conditional approval, deferred approval, and disapproval. Investigators must follow the approved protocols and regulations honestly, and it is the IRB's mission to audit clinical trial sites as well.
Ethics ; Ethics Committees, Research* ; Humans ; Missions and Missionaries* ; Research Personnel ; Social Control, Formal

BACKGROUND: This research is to identify the difficulties occuring in the course of managing the adverse events and the adverse event related standard operating procedure in the regulation of each institutional review board. METHODS: In order to identify the issues of the management of adverse events of each institution, this research surveyed the IRB administrators in fifty two university hospitals nation-wide. This survey is conducted among one chairman and one IRB member from the IRB members per each IRB who have experience in reviewing adverse events. The survey also includes investigators and sponsors who engage in reporting adverse events. RESULTS: The result of this survey demonstrates that the objects and the terms of adverse event reports provided by the Standard Operating Procedure and the KGCP of each institution are not very different from each other. However, according to the survey, any cases reported to the IRBs, although they are not specified as the object of reports in the institution, have been reviewed by the IRB members. To sum up the results of the survey, the major issues include ambiguous regulations on adverse event reports and reviews, the use of different report formats for each institution, and the difficulty with evaluating the causal relationship with Investigational Product. CONCLUSION: It is necessary to develop concrete and specified guidelines on the objects and the terms of reports, the standard for the causal relationship and the adequate measures for adverse events after review and to standardize the format of adverse event reporting.
Administrative Personnel ; Ethics Committees, Research ; Hospitals, University ; Humans ; Research Personnel ; Social Control, Formal

Clinical research has expanded tremendously in the past few decades and consequently there has been growing interest in the ethical guidelines that are being followed for the protection of human subjects. This review summarizes historical scandals and social responses chronologically from World War II to the Death of Ellen Roche (2001) to emphasize the lessons we must learn from history. International ethical guidelines for studies with human subjects are also briefly described in order to understand the circumstances of clinical research. The tasks and responsibilities of the institutions and investigators in human subject research to preserve the safety and welfare of research subjects are summarized. Next, several debated ethical issues and insights are arranged as controversial topics. This brief review and summary seeks to highlight important arguments and make suggestions to institutional review boards (IRBs) to contribute to the future evolution of ethics in clinical research as we advance forward.
Ethics Committees, Research ; Humans ; Research Personnel ; Research Subjects ; World War II

Experimental studies involve intervention and manipulation of study elements such as randomization of the participating groups. In general, experimental studies involving human are riskier than observational studies, demanding robust ethical vigilance and compliance among such stakeholders as investigators, sponsors, IRBs and health authorities. Social values of research should be counted as a primary ethical consideration in experimental research. It is unethical to put human subjects into uncertain and risky conditions if the study does not pursue valuable knowledge. Sound scientific design is prerequisite for good ethics. Risk-benefit ratio of the study must be carefully evaluated study. Not only risks from physical harms but also socio-economical and psychological harms from the study should be considered as risk of the study. Risks from the design of the study such as randomization and placebo must be carefully examined. Voluntary informed consent is essential in experimental studies involving human. Human subjects, before they decide to participate in the study, must be informed the followings: risks, benefits, experimental procedures, alternative treatment, compensation for injury, and participants' voluntariness and right to withdraw at anytime. Experimental studies are usually required written consent documentation and full institutional review board (IRB) review. Other elements of experimental research ethics includes special protection for high risk groups and various vulnerable groups, and protection of privacy and confidentiality.
Bioethics* ; Compensation and Redress ; Compliance ; Confidentiality ; Consent Forms ; Ethics ; Ethics Committees, Research ; Ethics, Research ; Humans ; Informed Consent ; Privacy ; Random Allocation ; Research Personnel ; Social Values

BACKGROUND: Oversight on the bioethical compliance of national R&D projects or research personnel is currently conducted exclusively by IRB (Institutional Review Board) within the relevant research institute. Considering current state of affairs in Korea, there is an imperative to establish a national oversight system for bioethical compliance, conduct comprehensive oversight on bioethical compliance of national R&D projects, and enhance subject protection system. METHODS: We examined opinions from researchers and IRB personnels regarding ethical oversight system on R&D projects. Additionally, we looked at IRB assessment by KAIRB (Korea Association of Institutional Review Board) in order to identify status and problems with current IRB system in Korea. Assessment was also done for four other countries (US, UK, Germany, Singapore) through in-person visits as well as surveys in writing for a total of 6 months (2012.12.1~2013.5.31). The research comprised of two aspects: system management and R&D project audit. Based on this, we examined current status and problems of the existing system in Korea and made recommendations for improvement. RESULTS: Regulatory objectives and backgrounds of biomedical researches are different from each country due to different characteristics of bioethical oversight system. This shows that each country sets up its own regulations and procedures to fit each situation. Bioethical compliance oversight system greatly varied between the countries. From this study, it can be seen that improvement of existing procedures and oversight system or establishment of new ones are essential in Korea. CONCLUSION: In terms of system management, a dedicated government organization need to be established for bioethical compliance, subject protection, IRB inspection, training, evaluation, and certification of systems, and also support for IRB e-system. Regarding R&D project oversight, it is essential to confirm IRB review results before start of a research, to conduct a review on ethical aspects of research plans, and to carry out continued oversight on bioethical compliance through interim reports.
Academies and Institutes ; Certification ; Compliance* ; Ethics Committees, Research ; Germany ; Humans ; Korea ; Research Personnel* ; Social Control, Formal ; Writing

Children are not small adults and there is a need to carry out specific trials that cannot be performed in adults. In general, children (minors) are unable to consent but their assent should be obtained using age appropriate information. Institutional Review Board (IRB) need paediatric expertise to balance the benefits and risks of research in children. The lack of consent has implications on the design, analysis and the choice of comparators used in the trials, which should only be performed by trained investigators with paediatric experience. Pain, fear, distress and parental separation should be prevented and minimised when unavoidable. The children requires even more careful review. Children represent a vulne rable population with developmental, physiological and psychological differences from adults, which make age- and development-related research important for their benefit. Finally, criteria for the protection of children in clinical trials there fore need to be laid down. Specific protection should be defined for research performed in children, at all stages and ages.
Adult ; Child ; Ethics Committees, Research ; Humans ; Parents ; Research Personnel ; Risk Assessment