ABSTRACT
The electronic informed consent (eIC) system is a product of modernization development of electronic and intelligent technology. In the context of COVID-19, the eIC system can adapt to the epidemic prevention and control requirements, showing its time-space advantages. By introducing the concept, form and the use of eIC system, this paper analyzed the challenges of acceptance, understanding, consent and information security faced by the eIC system. Based on this, some suggestions were put forward, including strengthening the training of the relevant personnel involved in the eIC system, enhancing and improving the functions of the eIC system, and perfecting the relevant laws and regulations of the eIC system, so as to provide reference for the future research and application of eIC. © 2023, Editorial department of Chinese Medical Ethics. All rights reserved.
ABSTRACT
The electronic informed consent (eIC) system is a product of modernization development of electronic and intelligent technology. In the context of COVID-19, the eIC system can adapt to the epidemic prevention and control requirements, showing its time-space advantages. By introducing the concept, form and the use of eIC system, this paper analyzed the challenges of acceptance, understanding, consent and information security faced by the eIC system. Based on this, some suggestions were put forward, including strengthening the training of the relevant personnel involved in the eIC system, enhancing and improving the functions of the eIC system, and perfecting the relevant laws and regulations of the eIC system, so as to provide reference for the future research and application of eIC. © 2023, Editorial department of Chinese Medical Ethics. All rights reserved.
ABSTRACT
The electronic informed consent (eIC) system is a product of modernization development of electronic and intelligent technology. In the context of COVID-19, the eIC system can adapt to the epidemic prevention and control requirements, showing its time-space advantages. By introducing the concept, form and the use of eIC system, this paper analyzed the challenges of acceptance, understanding, consent and information security faced by the eIC system. Based on this, some suggestions were put forward, including strengthening the training of the relevant personnel involved in the eIC system, enhancing and improving the functions of the eIC system, and perfecting the relevant laws and regulations of the eIC system, so as to provide reference for the future research and application of eIC. © 2023, Editorial department of Chinese Medical Ethics. All rights reserved.
ABSTRACT
The pandemic of Coronavirus Disease 2019 (COVID-19) has created paradoxically a good opportunity globally to conduct research in the field of health and social science, and a Lower Middle-Income Country (LMIC) like Nepal is not an exception in this regard. During this ongoing pandemic, the Ethical Review Board (ERB) of Nepal Health Research Council (NHRC) has received numerous research proposals regarding COVID-19. As its main responsibility is to ensure participants' safety, at the same time maintaining the scientific standard of research, the ERB has meticulously gone through all the proposals received so far. During this situation of a health emergency, the ERB of NHRC has had a different experience compared to the usual time. Its strength, weakness, opportunities, and threats have been like never before. Copyright © 2020, Kathmandu University. All rights reserved.
ABSTRACT
Presence of Nepal in global clinical trials has been visibly negligible despite the history of conducting large scaled randomized controlled trial on Hepatitis E vaccine decades ago. Majority of the problem is attributed to the lack of collaborative work, financial and human resource constrains. COVID-19 pandemics seems to have triggered urgency among the authorities of Nepal leading to a substantial increase in the number of clinical trials in collaboration with national and international organizations/institutions. Immediately after detection of the first COVID-19 case on 13 January 2020, the Ethical Review Board (ERB) of NHRC received several research proposals, subsequently leading to the approval of the first clinical trial for COVID-19 on 01 July 2020 to investigate potential of traditional Ayurveda based medicine for COVID treatment. Soon, number of other clinical trial proposals received approval and implemented in the country, however budgetary allocation from the Government of Nepal (GON) was prioritized for COVID-19 outrage management and vaccination coverage only. Collaborations with various international institutions played a significant role in the successful implementation of large-scale clinical trials in the country and further laid the path for future. In this review paper we present the recent developments in clinical trials in Nepal, budgetary allocation from the government and the mechanisms in place for regulation of clinical research in the country along with challenges and way forward.
ABSTRACT
To review systematically the progress of all domestic and foreign clinical trials since the emergence of the COVID-19 epidemic and the overview of human challenge study (HCS) in the past year, grasp relevant information of ethical review, and explores the feasibility of human challenge study and provide references for stake holders. Based on the Chinese Clinical Trial Registration Center and clinical trial. gov, clinical trials that were consistent with COVID-19 was searched, and the deadline was June 11, 2020.Basic information was extracted and the number of trials was selected from the research type, clinical stage, recruitment status, and ethical passing status. Literature search was conducted based on Pubmed between January 1, 2019 and June 11, 2020.According to the included literature, basic information was extracted and opinions were reported on HCS. 638 and 1935 clinical trials were carried out at home and abroad respectively, of which the number of clinical trials carried out in Hubei reached 323. China and the United States conducted more interventional trials, and the United States had the most clinical trials entered in Phase II, there were a total of 142. Most of the clinical trials were in the stage of recruiting research subjects. In addition, a total of 539 clinical trials in China had passed ethical approval. A total of 5 documents were included in the Human Challenge Study, four maintained a positive attitude towards HCS and put forward corresponding thinking about ethical review. Under the COVID-19, clinical trials for new drugs and new coronavirus vaccines have rapidly increased, which puts forward higher requirements for the progress of ethical review. In the face of such public health emergencies and special research, it is urgent to establish a sound ethical review system and an ethical review system, as well as to construct an ethical model for special research. © 2021, Editorial Board of Pharmaceutical Biotechnology. All right reserved.
ABSTRACT
High-quality clinical study on traditional Chinese medicine is of great significance to effectively control new public health emergencies represented by outbreaks of infectious diseases and ensure people's health and safety, but it still faces a series of ethical issues. Based on the seven core values of equity, good deeds, effectiveness, respect for individuals, freedom, reciprocity, and solida-rity proposed in the Guidelines for Management of Ethical Issues in Outbreaks of Infectious Diseases, this article emphasizes the characteristics and laws of clinical studies on traditional Chinese medicine. Main points of ethical review of traditional Chinese medicine were summarized in the aspects of overall concept, syndrome differentiation and treatment, prevention before disease onset, cultural value, and clinical basis. Based on the outbreak of coronavirus disease 2019(COVID-19), we collected relevant registered Chinese medicine clinical studies, summarized the core issues of the ethics review for COVID-19, and further improved the traditional Chinese medicine ethics review system and resources, so as to better serve ethical review and scientific studies in public health emergencies.
Subject(s)
Betacoronavirus , Coronavirus Infections , Ethical Review , Medicine, Chinese Traditional , Pandemics , Pneumonia, Viral , COVID-19 , Emergencies , Humans , Public Health , SARS-CoV-2ABSTRACT
The number of research involving human subjects on coronavirus disease 2019 (COVID-19) is surging, bringing challenges to the ethical review committee (ERC) in terms of reviewing speed and special ethical considerations under the pandemic. However, the existing ethical review system and regulations have their limitations to meet the demand for a prompt and efficient epidemic control. Since the research under the public health emergency is different from that carried out in familiar situations to design and implementation, the strategy for a satisfactory ERC response should balance the duty of protecting individual participants as well as the special public needs derived from the disease control. It is suggested that the ethical review-related regulations need to be updated, and a unified supervision system to the overall ERC is required. ERC collaboration, capacity-improving and efficiency-improving measures need to be taken. With respect to the reviewing guidelines, it is suggested that the international norms should be explained with more consideration of the local condition and the exceptional circumstances in this public health emergency. A joint effort needs to be taken for better research conduction.
Subject(s)
Betacoronavirus , Coronavirus Infections , Ethics Committees, Research/organization & administration , Pandemics , Pneumonia, Viral , Research Design , Therapeutic Human Experimentation/ethics , COVID-19 , Coronavirus Infections/diagnosis , Coronavirus Infections/therapy , Global Health , Humans , Informed Consent/ethics , Pneumonia, Viral/diagnosis , Pneumonia, Viral/therapy , SARS-CoV-2ABSTRACT
Objective@#Conduct comprehensive analysis of the regulatory requirement of ethical review regarding to the response of public health emergency, illustrate particular ethical review and ethical administration strategies for COVID-19 Emergency Research.@*Methods@#Theoretical discussion, case study and interpretation of international guidelines were adopted to explore challenges and possible best practices for ethical review of such research.@*Results@#The ethical review of COVID-19 emergency research should comply with regulatory requirement in general, combined with contextual background.@*Conclusions@#The ethical review approval criteria of COVID-19 emergency research should take into full consideration of its urgency to make sure efficient and high quality initial review, meanwhile, more attention should be paid on continuing ethical review and ethical consultation during the whole life-circle of COVID-19 Emergency Research.