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Ethics Committee Reviews of Applications for Research Studies Letters Figure. Severe Acute Respiratory Syndrome Coronavirus 2 Distribution and Shedding Patterns Among 20 Hospitalized Patients 10 Bronchoalveolar lavage fluid Pharyngeal swabs Fibrobronchoscopy brush biopsy 20 Feces Sputum Blood Nasal swabs 30 Urine Cycle threshold Cycle 40 The specimen with a cycle threshold 50 value above the dashed line is 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 interpreted as positive for Patient SARS-CoV-2 RNA; those under, negative. small. Further investigation of patients with detailed tempo- and Beijing for collection of specimens. None of these individuals received ral and symptom data and consecutively collected specimens compensation for their contributions. from different sites is warranted. 1. Tan W, Zhao X, Ma X, et al. Notes from the field: a novel coronavirus genome identified in a cluster of pneumonia cases—Wuhan, China 2019-2020. China CDC Weekly. 2020;2(4):61-62. Wenling Wang, PhD 2. Wang D, Hu B, Hu C, et al. Clinical characteristics of 138 hospitalized patients Yanli Xu, MD with 2019 novel coronavirus–infected pneumonia in Wuhan, China. JAMA. Ruqin Gao, MD Published February 7, 2020. doi:10.1001/jama.2020.1585 Roujian Lu, MPH 3. Zhang W, Du RH, Li B, et al. Molecular and serological investigation of Kai Han, BS 2019-nCoV infected patients: implication of multiple shedding routes. Emerg Microbes Infect. 2020;9(1):386-389. doi:10.1080/22221751.2020.1729071 Guizhen Wu, MD 4. Pan Y, Zhang D, Yang P, Poon LLM, Wang Q. Viral load of SARS-CoV-2 in Wenjie Tan, MD, PhD clinical samples. Lancet Infect Dis. Published online February 24, 2020. doi:10. 1016/S1473-3099(20)30113-4 Author Affiliations: National Institute for Viral Disease Control and Prevention, China CDC, Beijing, China (Wang, Lu, Wu, Tan); Beijing Ditan Hospital, Capital Medical University, Beijing, China (Xu, Han); Qingdao Municipal Center for Ethics Committee Reviews of Applications Disease Control and Prevention, Qingdao, China (Gao). for Research Studies at 1 Hospital in China Accepted for Publication: March 5, 2020. During the 2019 Novel Coronavirus Epidemic Corresponding Author: Wenjie Tan, MD, PhD, National Institute for Viral Disease Control and Prevention, China CDC, 155 Changbai Rd, Changping Since December 2019, an epidemic of coronavirus disease District, Beijing 102206, China ([email protected]). 2019 (COVID-19) has spread rapidly from Wuhan, Hubei 1 Published Online: March 11, 2020. doi:10.1001/jama.2020.3786 Province, China. As of March 7, there were 1272 confirmed Author Contributions: Drs Wang and Tan had full access to all of the data in the coronavirus cases in Henan Province (the third-highest in study and take responsibility for the integrity of the data and the accuracy of China), which adjoins Hubei Province. Due to the high conta- the data analysis. Drs Wang and Xu contributed equally. giousness of COVID-19 and the current lack of any effective Concept and design: Wang, Xu, Wu, Tan. Acquisition, analysis, or interpretation of data: Xu, Gao, Lu, Han, Tan. vaccine or drug, scientists and physicians are conducting a Drafting of the manuscript: Wang, Xu, Gao, Han, Tan. series of clinical studies involving affected patients. In 2016, Critical revision of the manuscript for important intellectual content: Xu, Lu, the World Health Organization (WHO) published “Guidance Wu, Tan. for Managing Ethical Issues in Infectious Disease”2 to ensure Statistical analysis: Wang. Obtained funding: Wang, Tan. the scientific validity of and participants’ rights and safety in Administrative, technical, or material support: Xu, Gao, Lu, Han, Wu. studies conducted during outbreaks. The guidance stated Supervision: Xu, Wu, Tan. that there is a moral obligation to conduct timely scientific Conflict of Interest Disclosures: None reported. research. The Ethics Committee of the Henan Provincial Funding/Support: This work was supported by grants 2016YFD0500301 and People’s Hospital reviewed the COVID-19 studies from the 2020YFC0840900 from the National Key Research and Development hospital based on those guidelines. Program of China and 2018ZX10101002 from the National Major Project for Control and Prevention of Infectious Disease in China. Role of the Funder/Sponsor: The sponsors had no role in the design and Methods | Henan Provincial People's Hospital is a designated conduct of the study; collection, management, analysis, and interpretation of hospital for COVID-19. The ethics committee designed a the data; preparation, review, or approval of the manuscript; and decision to review system for research proposals at the beginning of the submit the manuscript for publication. epidemic, including the use of emergency video conference Additional Contributions: We thank Gary Wong, PhD (CAS Key Laboratory of to review batches of project applications. Electronic docu- Molecular Virology & Immunology, Institute Pasteur of Shanghai, Chinese Academy of Sciences, Shanghai, China) for English revision of the manuscript, ments were formally reviewed by the secretary and sent and clinical staff members in hospitals in Hubei Province, Shandong Province, to members of the committee to review in advance of the 1844 JAMA May 12, 2020 Volume 323, Number 18 (Reprinted) jama.com © 2020 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 10/01/2021 Letters Table 1. Protocols Referred for Modification No. (%) of studies needing modifications a Inclusion criteria were too broad, or Reasons studies needed modifications (n = 31) exclusion criteria were too narrow. Lack of statistical basis for sample-size calculation 12 (38.7) b The treatment scheme for expected a Defective inclusion and exclusion criteria 10 (32.3) adverse reactions was incomplete Defective efficacy and safety indicators 8 (25.8) or the criteria for early termination of the study was unclear. Study participants’ risk minimization criteria insufficientb 8 (25.8) c The preclinical data or the Benefits for future patients or society not described clearly 5 (16.1) mechanism of the drug was not fully Insufficient team members in key roles 4 (12.9) provided. Necessary research equipment not available 4 (12.9) d Operating procedures of plasma Background evidence not provided sufficientlyc 3 (9.7) treatment, cell therapy, traditional Chinese medicine therapy were not Operating procedures need improvementd 3 (9.7) standard. meetings. Applications were voted on by quorum and mem- Table 2. Informed Consent Forms Needing Modification bers proposed clear reasons for the decisions and provided No. (%) of studies suggestions for revision after full discussion. Reasons informed consent forms needing modifications We examined all new applications for COVID-19–related needed modifications (n = 31) studies and meeting minutes from February 2 through Research risks not explained completely 13 (41.9) March 7, 2020, categorized the study type, determined the ap- Compensation of participant not reasonable 13 (41.9) Misrepresentative language used proval rate and review time, and summarized the issues in re- 8 (25.8) to induce participation search proposals and informed consent forms consistent with Language barriers 8 (25.8) the WHO document. Follow-up reviews of ongoing non– Participation steps not described clearly 7 (22.6) COVID-19 studies are not included in this study. Benefits for participants not described objectively 7 (22.6) Results | Ethics review conferences, held once every month in Free items offered by sponsor not declared clearly 6 (19.4) Alternative treatment strategy not explained nonepidemic periods, were held 4 times in 35 days. The mean 5 (16.1) sufficiently time was 2.13 days from application submissions until an ini- Responsibility for research-related injuries 5 (16.1) tial review decision was made. For applications that required not declared clearly modifications, the mean time was 1.81 days for the resubmis- sion to be reviewed again. view after the initial request.3 However, the first-time study Forty-one applications were reviewed, including inter- approval rate of 14.6 % was lower than 33.4% during the non- ventional studies (n = 21); diagnostic studies (n = 7); obser- epidemic period in 2019 in the Henan Provincial People's Hos- vational studies (n = 10); and other types (n = 3). Six (14.6%) pital, possibly reflecting researchers’ inexperience and the were approved; 4 (9.8%), rejected; and 31 (75.6%), referred hasty preparation of documents. Review standards were not for modification. lowered during the outbreak. Of the 4 rejected applications, 2 were denied because 1 The high frequency of issues with the research proposals involved a new, unapproved interferon-alfa treatment and and informed consent forms reflect that during an outbreak, another involved traditional Chinese medicine with many researchers may use experimental drugs on affected pa- potential adverse reactions, so the potential risks out- tients, relax inclusion and exclusion criteria, and fail to offer weighed benefits. The other 2 studies were denied because reasonable compensation or to inform vulnerable patients of the laboratory biosafety level was inadequate, which may trial risks. Because the climate of fear may induce patients to have led to virus leakage. agree to participate in research, the ethics committee paid spe- Of the 31 applications that required modifications, the is- cial attention to such issues. sues with the research proposals and informed consent forms This study was limited to a small number of studies con- are indicated in Table 1 and
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