Subject(s)
Betacoronavirus , Clinical Studies as Topic/statistics & numerical data , Coronavirus Infections/therapy , Global Health/statistics & numerical data , Pneumonia, Viral/therapy , Registries/statistics & numerical data , Advisory Committees , COVID-19 , Coronavirus Infections/epidemiology , France/epidemiology , Humans , Observational Studies as Topic/statistics & numerical data , Pandemics , Pneumonia, Viral/epidemiology , Prospective Studies , Randomized Controlled Trials as Topic/statistics & numerical data , Risk Assessment , SARS-CoV-2 , Therapeutic Human Experimentation/ethicsSubject(s)
COVID-19 Vaccines , COVID-19/prevention & control , Clinical Trials as Topic/ethics , Pregnancy Complications, Infectious/prevention & control , Clinical Trials as Topic/legislation & jurisprudence , Female , Government Regulation , Humans , Lactation , Pregnancy , Therapeutic Human Experimentation/ethicsSubject(s)
Betacoronavirus , Clinical Trials, Phase III as Topic/ethics , Coronavirus Infections/prevention & control , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Prisoners , Therapeutic Human Experimentation/ethics , Vaccination/ethics , Viral Vaccines , COVID-19 , COVID-19 Vaccines , Humans , SARS-CoV-2 , United StatesABSTRACT
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.