The ethics of COVID-19 clinical trials: New considerations in a controversial area

In December 2019, coronavirus disease 2019 (COVID-19) was iscovered in Wuhan, Hubei province, China, which has caused evere illness and death.1 China is the most populous country in the orld with a population of 1.428 billion.2 With 11 million inhabtants, Wuhan is the largest transportation hub in central China, hich is known as Chicago of China.2,3 China has taken a series of ublic health interventions to control the epidemic. 3 The outbreak f COVID-19 has become a public health event of global concern.4 ue to its relatively high infectivity, the rapid progression of the isease and the lack of clear and effective treatment, it has caused nternational anxiety.4,5 In fact, it has also caused illness in a signifiant proportion of exposed medical personnel.6 Since identification f COVID-19 was confirmed in December 2019, the number of cases as shown an upward trend, and the epidemiological picture is hanging every day. With lack of any effective vaccine or drug urrently available, scientists and doctors are conducting a series f clinical studies involving affected patients.7,8 Although Chinese esearchers are struggling to find effective treatments and prevenive measures, and actively conduct clinical trials, one aspect of the linical trials has been surprisingly overlooked. That’s the ethics f clinical trials. In 2016, the World Health Organization (WHO) eleased the “Guidance for Managing Ethical Issues in Infectious isease” to ensure the safety of participants during the outbreak of isease.9 The guidance notes that it is morally obligatory to conuct scientific research in a timely manner. As of April 5, 2020, the hinese Clinical Trials Registry (www.chictr.org.cn) has registered total of 556 COVID-19 clinical trials. Most of these studies are nterventional studies, which included randomized controlled trils (RCTs), followed by observational studies, diagnostic studies and ther types.10 Although the design of some studies may be flawed ue to the lack of time. However, it is the ethics of trials that need pecial attention. We have a few comments on this issue. On the one hand, the focus of ethical issues is the protection f the subjects’ rights and interests. In clinical trials, the investiator or applicant should first consider how to protect the rights f the subjects. Specifically, the subjects’ rights of voluntary paricipation, the right to know, the right to privacy, the right to