The Practice and Experience of the Standardized Operation in Ethical Review in Human Involved Biomedical Research
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Abstract:
In cognizance of the current situation of that it is difficult to synchronize the links in declaration,implementation and supervision of ethical review in human involved biomedical research,this essay explore the standardized operation regulations and rules for the ethical review of biomedical research of hospital ethics committee.During the review the experience has been obtained that the continuing education of the ethical commission should be enhanced;the ethical supervision of the key links be strengthened;the ethical review capacity of the commissioners be continuously improved;the information management be emphasized;the multi-channel communications be established and the importance be attached to the ethical direction to scientific researchers.Keywords:
Declaration
Ethical standards
Human research
Research Ethics
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Abstract Ethics and ethical behaviour are the fundamental pillars of a civilised society. The focus on ethical behaviour is indispensable in certain fields such as medicine, finance, or law. In fact, ethics gets precedence with anything that would include, affect, transform, or influence upon individuals, communities or any living creatures. Many institutions within Europe have set up their own committees to focus on or approve activities that have ethical impact. In contrast, lesser-developed countries (worldwide) are trying to set up these committees to govern their academia and research. As the first European consortium established to assist academic integrity, European Network for Academic Integrity (ENAI), we felt the importance of guiding those institutions and communities that are trying to conduct research with ethical principles. We have established an ethical advisory working group within ENAI with the aim to promote ethics within curriculum, research and institutional policies. We are constantly researching available data on this subject and committed to help the academia to convey and conduct ethical behaviour. Upon preliminary review and discussion, the group found a disparity in understanding, practice and teaching approaches to ethical applications of research projects among peers. Therefore, this short paper preliminarily aims to critically review the available information on ethics, the history behind establishing ethical principles and its international guidelines to govern research. The paper is based on the workshop conducted in the 5th International conference Plagiarism across Europe and Beyond, in Mykolas Romeris University, Lithuania in 2019. During the workshop, we have detailed a) basic needs of an ethical committee within an institution; b) a typical ethical approval process (with examples from three different universities); and c) the ways to obtain informed consent with some examples. These are summarised in this paper with some example comparisons of ethical approval processes from different universities. We believe this paper will provide guidelines on preparing and training both researchers and research students in appropriately upholding ethical practices through ethical approval processes.
Research Ethics
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Ethical issues have been the kind of problems that we have to face in medical research.The article,from the perspective of ethical problems in medical research,on the basis of analyzing the reasons and harms of the problem,puts forward the following strategies,such as,strengthen ethical consciousness of the medical scientific research personnel,reinforce ethical responsibility of the medical scientific research personnel,play the role of supervision by the ethical review,improve the scientific management system and system construction.In order to realize the medical purpose,we must put heart and soul into for the people the mental and physical health services.
Key words:
Medical research; Ethics ; Medical Morality ; Humanism
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Ethics is a system of moral principles that not only applies values and judgments to medical practice, but also to any research that deals with human participants. Before pursuing any research, it is mandatory for a researcher to have some basic information about the ethics and ethical guidelines. Hence, the purpose of this review article is to give a brief insight into the ethics and ethical guidelines to Biomedical Research.
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The increasing emphasis on evidence-based clinical practice has thrown into sharp focus multiple deficiencies in current systems of ethical review. This paper argues that a complete overhaul of systems for ethical oversight of studies involving human subjects is now required as developments in medical, epidemiological and genetic research have outstripped existing structures for ethical supervision. It shows that many problems are now evident and concludes that sequential and piecemeal amendments to present arrangements are inadequate to address these. At their core present systems of ethical review still rely on the integrity and judgment of individual investigators. One possible alternative is to train and license research investigators, make explicit their responsibilities and have ethics committees devote much more of their time to monitoring research activity in order to detect those infringing the rules.
Research Ethics
Bioethics
Human research
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Biomedical research that involves human subjects requires compliance with ethical principles and guidelines. The ethical and scientific standards of research have been thoroughly discussed by international ethical guidelines and declarations. Compliance with these ensures the autonomy, dignity and well-being of research subjects; as well as the integrity and credibility of research results. Research ethics committees (RECs) are mandated to ensure that research proposals are scientifically sound and ethical. In this review, we define RECs in laboratory medicine and describe their role based on the examination of the requirements of ethical research; discuss particular ethical issues that arise in laboratory medicine research using biological samples, what challenges they face and how they can ensure the quality of their review. RECs need to be put into a broader framework that ensures institutional governance with continuous evaluation and auditing that ensure the quality of ethical review.
Research Ethics
Dignity
Scientific Integrity
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In this article,the authors at first discussed the two lessons from Golden Rice trials,that is,ability of ethical review and the supervision and management on ethical review committee in human involved researches need to be strengthened. Secondly,they discussed the research ethical foundation,namely the principles of subservience,respect and fairness. At last,they expressed their opinions on several ethical and regulatory issues related with institutional review boards and proposed that authoritative multidisciplinary experts could set up a corresponding institution to check and evaluate the activities of ethics committee.
Foundation (evidence)
Institution
Ethics committee
Institutional review board
Research Ethics
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Presently, there is a movement in the UK research governance framework towards what is referred to as proportional ethical review. Proportional ethical review is the notion that the level of ethical review and scrutiny given to a research project ought to reflect the level of ethical risk represented by that project. Relatively innocuous research should receive relatively minimal review and relatively risky research should receive intense scrutiny. Although conceptually attractive, the notion of proportional review depends on the possibility of effectively identifying the risks and ethical issues posed by an application with some process other than a full review by a properly constituted research ethics committee. In this paper, it is argued that this cannot be achieved and that the only appropriate means of identifying risks and ethical issues is consideration by a full committee. This implies that the suggested changes to the National Health Service research ethics system presently being consulted on should be strenuously resisted.
Scrutiny
Research Ethics
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Abstract Medical research has the potential to create huge benefits to society and enhance the professional reputation of the researchers responsible for the discoveries. However, a researcher must never knowingly compromise the welfare of a research participant, irrespective of how important the research outcomes are to society in general. This article aims to educate clinical researchers in the common pitfalls of human experimentation and ways to avoid these ethical problems in pharmaceutical trials.
Compromise
Research Ethics
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Medical Research
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Objective
To improve the ethics review process and ethical standards, strengthen the implantation of ethical review of research involving human subject in our hospital.
Methods
Evaluating the review practice of research involving human subject in our hospital practices, learn and bring in the latest international experiences.
Results
As China's Ethical Committee is in its initial stage, the regulatory ability is still in defective and insufficient. A healthy and operable ethic review mechanism needs to be perfected gradually along with the practice.
Conclusions
In the aspect of improving the ethical review work of human subject research, some new methods and ideas were discussed. In addition to strengthen the current organizational system, we should clarify the elements of the review of different types of research and carry out multi-level ethical trainings. The establishment of a unified, specific evaluative system, combined with this information platform is continuously monitoring the clinical study. This will ensure the human research projects comply with ethical requirements, and further promote the sustainable development of clinical research.
Key words:
Ethical Committee; Human research; Ethical review
Ethical standards
Ethical Leadership
Human research
Clinical Practice
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With the rapid development of biotechnology, ethical issues of scientific activities are more and more serious, while the ethical review as the main means of suppressing research ethics problems, it also has many problems in the process of practice. This article from the ethics review committee’s organizational structure, operation specifications, capacity, the scope of review and external regulation summarize the main problems of China's research ethics review, and on this basis, we put forward the corresponding countermeasures, hoping to provide certain reference of our country's research ethics review practice, and to better safeguard the healthy development of our country's scientific research.
Scope (computer science)
Research Ethics
Safeguard
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