Lack of Ethics Approval Disclosure in a Multicenter Newborn Study in China


A study [1] published on PLoS ONE did not disclose the ethic approval numbers, although the authors claimed that the study "was approved by the Ethical Committee of the participating hospitals".

According to the article, a total of 29,601 newborns (with 15,365 males, and 14,236 females) were prospectively recruited from eight hospitals in China, including Hainan Woman and Children’s Medical Center, Guangzhou Woman and Children’s Medical Center, the First People’s Hospital of Yunnan Province, Chongqing Health Center for Women and Children, Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine, Jinan Maternity and Child Care Hospital, Shijiazhuang Maternal and Child Health Care Hospital, as well as Inner Mongolia Maternity and Child Health Care Hospital.

Dried blood spot specimens were collected after the births to test for glucose-6-phosphate dehydrogenase deficiency among those newborns. Researchers were required to obtain the ethic approval before their study, as well as to obtain written informed consent from the parents before the specimens were collected. Although the researchers claimed they did so, they did not disclose the ethic approval numbers on the article, raising our concerns.



Reference

[1] 10.1371/journal.pone.0310517






Author: WU Guangheng

Founder and Chair of the 5GH Foundation

E-Mail: wu@5gh.org.cn

Document ID: 5GH-WuGH-20241207.001

Publication Date: 2024.12.07

This article is licensed under a CC BY-NC-ND 4.0 International License

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