May 12, 2020, Vol 323, No. 18, Pages 1749-1862
Ethics Committee Reviews of Applications for Research Studies at 1 Hospital in China During the 2019 Novel Coronavirus Epidemic
Hui Zhang, MBBS; Fengmin Shao, MD, PhD; Jianqin Gu, MD, PhD; et al.
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JAMA. 2020;323(18):1844-1846. doi:10.1001/jama.2020.4362
This study reviews research ethics committee applications for COVID-19–related research at a Chinese hospital in February 2020 to characterize study type, approval rate and review time, reason for revision or denial, and issues with informed consent.
Ethics review conferences, held once every month in nonepidemic periods, were held 4 times in 35 days. The mean time was 2.13 days from application submissions until an initial review decision was made. For applications that required modifications, the mean time was 1.81 days for the resubmission to be reviewed again.
Forty-one applications were reviewed, including interventional studies (n = 21); diagnostic studies (n = 7); observational studies (n = 10); and other types (n = 3). Six (14.6%) were approved; 4 (9.8%), rejected; and 31 (75.6%), referred for modification.
Of the 4 rejected applications, 2 were denied because 1 involved a new, unapproved interferon-alfa treatment and another involved traditional Chinese medicine with many potential adverse reactions, so the potential risks outweighed benefits. The other 2 studies were denied because the laboratory biosafety level was inadequate, which may have led to virus leakage.
Of the 31 applications that required modifications, the issues with the research proposals and informed consent forms are indicated in Table 1 and Table 2. The most frequent issues with proposals were lack of statistical basis for the sample size calculation and deficiencies in inclusion and exclusion criteria. The most frequent issues with informed consent forms were that patients were not informed of the risks and that compensation was unreasonable.