Brain-computer interface(BCI)technology is rapidly advancing in medical research and application.As an emerging biomedical engineering technology,it has garnered significant attention in the clinical research of brain...Brain-computer interface(BCI)technology is rapidly advancing in medical research and application.As an emerging biomedical engineering technology,it has garnered significant attention in the clinical research of brain disease diagnosis and treatment,neurological rehabilitation,and mental health.However,BCI also raises several challenges and ethical concerns in clinical research.In this article,the authors investigate and discuss three aspects of BCI in medicine and healthcare:the state of international ethical governance,multidimensional ethical challenges pertaining to BCI in clinical research,and suggestive concerns for ethical review.Despite the great potential of frontier BCI research and development in the field of medical care,the ethical challenges induced by itself and the complexities of clinical research and brain function have put forward new special fields for ethics in BCI.To ensure"responsible innovation"in BCI research in healthcare and medicine,the creation of an ethical global governance framework and system,along with special guidelines for cutting-edge BCI research in medicine,is suggested.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
Laboratory animals and animal experiments are foundations and important support conditions for life sciences, especially for medical research. The animal experiments have drawn extensive attention from the society bec...Laboratory animals and animal experiments are foundations and important support conditions for life sciences, especially for medical research. The animal experiments have drawn extensive attention from the society because of the ethical issue. This paper takes Wenzhou Medical University as an example to give a brief introduction to the ethical review about laboratory animals in the university so as to further draw attention and concerns from the public about the ethical issue of laboratory animals. We successively introduce its scientific projects, nurturing environment and ethical review of laboratory animals.展开更多
Introduction: The Research Ethical Committee (REC) is responsible for the ethical evaluation of the projects presented by the scientific community to inform and train the members and researchers. Objective: To describ...Introduction: The Research Ethical Committee (REC) is responsible for the ethical evaluation of the projects presented by the scientific community to inform and train the members and researchers. Objective: To describe the purpose, composition and function of the REC of the Association of Social Pioneers (APS) located in the Sarah Rehabilitation’s Hospital (Brasilia, Brazil). Methodology: Descriptive analysis of the REC/APS based on 2013’s collected data was done. Results: The REC/APS is an independent collegiate body, which was established in 1998 in accordance with Brazilian regulation. The main objective is promoting the application of ethical principles and human rights in research involving humans. The REC was composed by chairperson and a substitute;secretary, fourteen regular members and five substitutes. We analyzed 164 projects submitted. The minimum time to a committee member who came up with the first opinion has been estimated as 14 days and the insurance of the consolidation occurred in 30 days. We approved 64 projects, of which 25 had pendencies in the first analysis, one project failed and 99 were excluded. The main problems were related to the writing of informed consent and the multicenter projects that did not include aspects such as costs, schedule and methodological limitations. We observed that the researcher could provide assistance. We considered the important role of the REC/APS to ensure trust between researchers and participants in the research. Conclusion: Despite the purpose, composition and function of the APS research ethical committee, there were encountered many obstacles in its formation, considering monitoring the progress of the research, national normative, international researches and others. The ethical committee does a vital public service with the variety of the specialized views on the meeting. We need to strike a balance and we must weigh up risks and benefits related to knowledge, in its essence, to research’s participant and its relevant social participation.展开更多
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
基金supported by the Ministry of Science and Tech-nology of the People's Republic of China(2021ZD0201900),Project 5(2021ZD0201905).
文摘Brain-computer interface(BCI)technology is rapidly advancing in medical research and application.As an emerging biomedical engineering technology,it has garnered significant attention in the clinical research of brain disease diagnosis and treatment,neurological rehabilitation,and mental health.However,BCI also raises several challenges and ethical concerns in clinical research.In this article,the authors investigate and discuss three aspects of BCI in medicine and healthcare:the state of international ethical governance,multidimensional ethical challenges pertaining to BCI in clinical research,and suggestive concerns for ethical review.Despite the great potential of frontier BCI research and development in the field of medical care,the ethical challenges induced by itself and the complexities of clinical research and brain function have put forward new special fields for ethics in BCI.To ensure"responsible innovation"in BCI research in healthcare and medicine,the creation of an ethical global governance framework and system,along with special guidelines for cutting-edge BCI research in medicine,is suggested.
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 fund of science and technology project of Wenzhou(Y20140601)
文摘Laboratory animals and animal experiments are foundations and important support conditions for life sciences, especially for medical research. The animal experiments have drawn extensive attention from the society because of the ethical issue. This paper takes Wenzhou Medical University as an example to give a brief introduction to the ethical review about laboratory animals in the university so as to further draw attention and concerns from the public about the ethical issue of laboratory animals. We successively introduce its scientific projects, nurturing environment and ethical review of laboratory animals.
文摘Introduction: The Research Ethical Committee (REC) is responsible for the ethical evaluation of the projects presented by the scientific community to inform and train the members and researchers. Objective: To describe the purpose, composition and function of the REC of the Association of Social Pioneers (APS) located in the Sarah Rehabilitation’s Hospital (Brasilia, Brazil). Methodology: Descriptive analysis of the REC/APS based on 2013’s collected data was done. Results: The REC/APS is an independent collegiate body, which was established in 1998 in accordance with Brazilian regulation. The main objective is promoting the application of ethical principles and human rights in research involving humans. The REC was composed by chairperson and a substitute;secretary, fourteen regular members and five substitutes. We analyzed 164 projects submitted. The minimum time to a committee member who came up with the first opinion has been estimated as 14 days and the insurance of the consolidation occurred in 30 days. We approved 64 projects, of which 25 had pendencies in the first analysis, one project failed and 99 were excluded. The main problems were related to the writing of informed consent and the multicenter projects that did not include aspects such as costs, schedule and methodological limitations. We observed that the researcher could provide assistance. We considered the important role of the REC/APS to ensure trust between researchers and participants in the research. Conclusion: Despite the purpose, composition and function of the APS research ethical committee, there were encountered many obstacles in its formation, considering monitoring the progress of the research, national normative, international researches and others. The ethical committee does a vital public service with the variety of the specialized views on the meeting. We need to strike a balance and we must weigh up risks and benefits related to knowledge, in its essence, to research’s participant and its relevant social participation.
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.
