Background: The Institutional Review Board (IRB) or Research Ethics Committees (RECs) is established to review the research proposals and ensure that participants’ ethical standards, scientific merit, and human right...Background: The Institutional Review Board (IRB) or Research Ethics Committees (RECs) is established to review the research proposals and ensure that participants’ ethical standards, scientific merit, and human rights are protected. Purpose: The authors report the experience of the REC at Qassim Region, Saudi Arabia over 10 years period. Methods: All proposals submitted to Qassim REC during the period 2008-2017 were studied using a 30 items data collection form based on The National Committee of Bioethics Regulations. Data extracted included;principal investigator characteristics, numbers of proposals reviewed, applications completeness, approval decision status, reported ethical issues, classification of the ethical review, and committee review duration. The structure, workload, and review process of Qassim REC were addressed redundant. Results: During 10 years, Qassim Research Ethics Committee (QREC) witnessed a progressive increase in the number of submitted proposals, from 9 to 149 proposals. Out of 508 submitted applications, 439 (86.4%) proposals were eligible for ethical review. Of these, 50 (11.4%) proposals were incomplete due to nonresponse of the principal investigators to the QREC comments. The final decision was made for 389 (88.6%) completed proposals. The approval rate was 85.4%, while the rejection rate was only 1.1%. The median time taken for ethical review was 13 days. Proposals that underwent full board review had a long review duration (Median: 19 days) in comparison to the expedited review (Median: 10 days). Incomplete Committee requirements, unclear research methodology, or possible ethical violation opportunities were the main reasons for delayed decisions. Conclusion: The workload of the Qassim ethics committee is high and growing progressively. However, the process indicators as per National Bioethics Committee rules were satisfactory. Rejection of proposals was rare as most of the reviewed proposals were descriptive studies with infrequent ethical matters.展开更多
The objectives of this article are as follows: 1) to propose a university research ethics system framework, 2) to provide a brief anatomy of the Meru University of Science and Technology (MUST) Institutional Research ...The objectives of this article are as follows: 1) to propose a university research ethics system framework, 2) to provide a brief anatomy of the Meru University of Science and Technology (MUST) Institutional Research Ethics Review Committee (MIRERC), 3) to perform a SWOT (Strengths, Weaknesses, Opportunities, and Threats) analysis of MIRERC, and 4) to make recommendations for improving its performance. The 13-member multi-disciplinary MIRERC was established in April 2017 to provide effective ethical oversight of research undertaken by the University’s scholarly community. Strengths of the MUST research ethics review system include a functional MIRERC, a pertinent national law and ethical guidelines, an Innovation and Enterprise Centre that could house a dedicated MIRERC Secretariat, and a supportive University Management Board. The weaknesses include lack of graduate schools to assure scientific rigor of proposals before submission to the MIRERC, lack of research ethics training in most school’s curricula, absence of a dedicated MIRERC Secretariat, undergraduate research proposals being not ethically reviewed, dearth of faculty trained in research ethics, and lack of an operating budget for MIRERC work. The opportunities include existence of about 22 accredited Institutional Research Ethics Review Committees (IRERC) in Kenya, existence of international standards and operational guidance for ethics review, availability of guidelines and codes of best ethical practices in research, existence of a free automated platform called Research for Health Innovation Organizer (RHInnO) Ethics for managing the ethics review process, and availability of external resources for strengthening IRERCs. In order to improve the performance and sustainability of the MUST research ethics system, there is need to include research ethics training in all undergraduate and post-graduate curricula, create a dynamic database of potential research ethics reviewers, allocate a percentage of the annual MUST research budget for MIRERC operations, charge a graduated fee for proposal ethics review, require all students’ and faculties’ internal and external research proposals be cleared by the MIRERC, and use the RHInnO Ethics platform to manage the ethics review process.展开更多
As one of the significant parts of medical science research in China,the research on Chinese medicine（CM） reflects the essence of healthcare tradition in the country both theoretically and clinically, and embodies t...As one of the significant parts of medical science research in China,the research on Chinese medicine（CM） reflects the essence of healthcare tradition in the country both theoretically and clinically, and embodies the values of Chinese culture.Therefore,in the practice of ethics review on CM research protocols,besides abiding by the contemporary prevalent international principles and guidelines on bioethics, which emphasizes the scientific and bioethical value of the study,we should also stress the CM theoretical background and relevant clinical experience in the framework of Chinese culture and values.In this paper, we went over the traits of CM clinical research and the experience from the practice of ethics review by the institution review board for bioethics,and then attempted to summarize the key points for the bioethics review to CM researches in China,so as to serve as reference for the bioethics review to traditional and alternative medicine researches.展开更多
文摘Background: The Institutional Review Board (IRB) or Research Ethics Committees (RECs) is established to review the research proposals and ensure that participants’ ethical standards, scientific merit, and human rights are protected. Purpose: The authors report the experience of the REC at Qassim Region, Saudi Arabia over 10 years period. Methods: All proposals submitted to Qassim REC during the period 2008-2017 were studied using a 30 items data collection form based on The National Committee of Bioethics Regulations. Data extracted included;principal investigator characteristics, numbers of proposals reviewed, applications completeness, approval decision status, reported ethical issues, classification of the ethical review, and committee review duration. The structure, workload, and review process of Qassim REC were addressed redundant. Results: During 10 years, Qassim Research Ethics Committee (QREC) witnessed a progressive increase in the number of submitted proposals, from 9 to 149 proposals. Out of 508 submitted applications, 439 (86.4%) proposals were eligible for ethical review. Of these, 50 (11.4%) proposals were incomplete due to nonresponse of the principal investigators to the QREC comments. The final decision was made for 389 (88.6%) completed proposals. The approval rate was 85.4%, while the rejection rate was only 1.1%. The median time taken for ethical review was 13 days. Proposals that underwent full board review had a long review duration (Median: 19 days) in comparison to the expedited review (Median: 10 days). Incomplete Committee requirements, unclear research methodology, or possible ethical violation opportunities were the main reasons for delayed decisions. Conclusion: The workload of the Qassim ethics committee is high and growing progressively. However, the process indicators as per National Bioethics Committee rules were satisfactory. Rejection of proposals was rare as most of the reviewed proposals were descriptive studies with infrequent ethical matters.
文摘The objectives of this article are as follows: 1) to propose a university research ethics system framework, 2) to provide a brief anatomy of the Meru University of Science and Technology (MUST) Institutional Research Ethics Review Committee (MIRERC), 3) to perform a SWOT (Strengths, Weaknesses, Opportunities, and Threats) analysis of MIRERC, and 4) to make recommendations for improving its performance. The 13-member multi-disciplinary MIRERC was established in April 2017 to provide effective ethical oversight of research undertaken by the University’s scholarly community. Strengths of the MUST research ethics review system include a functional MIRERC, a pertinent national law and ethical guidelines, an Innovation and Enterprise Centre that could house a dedicated MIRERC Secretariat, and a supportive University Management Board. The weaknesses include lack of graduate schools to assure scientific rigor of proposals before submission to the MIRERC, lack of research ethics training in most school’s curricula, absence of a dedicated MIRERC Secretariat, undergraduate research proposals being not ethically reviewed, dearth of faculty trained in research ethics, and lack of an operating budget for MIRERC work. The opportunities include existence of about 22 accredited Institutional Research Ethics Review Committees (IRERC) in Kenya, existence of international standards and operational guidance for ethics review, availability of guidelines and codes of best ethical practices in research, existence of a free automated platform called Research for Health Innovation Organizer (RHInnO) Ethics for managing the ethics review process, and availability of external resources for strengthening IRERCs. In order to improve the performance and sustainability of the MUST research ethics system, there is need to include research ethics training in all undergraduate and post-graduate curricula, create a dynamic database of potential research ethics reviewers, allocate a percentage of the annual MUST research budget for MIRERC operations, charge a graduated fee for proposal ethics review, require all students’ and faculties’ internal and external research proposals be cleared by the MIRERC, and use the RHInnO Ethics platform to manage the ethics review process.
基金Supported by the Major Projects of National Science and Technology"Research Project Technology Platform for Clinical Evaluation of New Drugs of Chinese Medicine"(No. 2008ZX09312-021)
文摘As one of the significant parts of medical science research in China,the research on Chinese medicine（CM） reflects the essence of healthcare tradition in the country both theoretically and clinically, and embodies the values of Chinese culture.Therefore,in the practice of ethics review on CM research protocols,besides abiding by the contemporary prevalent international principles and guidelines on bioethics, which emphasizes the scientific and bioethical value of the study,we should also stress the CM theoretical background and relevant clinical experience in the framework of Chinese culture and values.In this paper, we went over the traits of CM clinical research and the experience from the practice of ethics review by the institution review board for bioethics,and then attempted to summarize the key points for the bioethics review to CM researches in China,so as to serve as reference for the bioethics review to traditional and alternative medicine researches.
