A stem cell study published in the journal Nature last year and led by a team at the state-backed Chinese Academy of Sciences did not receive the required ethical approval, according to the CAS ethics committee office.
Yang Weiping, director of the CAS office, said the researcher involved had falsified paperwork during the process of publishing the paper to show the study had ethical approval when it did not.
The researcher was given a warning, suspended as a postgraduate supervisor for a year, and had some of his research funding cut, Yang told China Science Daily, the academy’s official newspaper. He did not name the researcher.
“We think this is serious because ethical review prior to starting a study is a red line that cannot be crossed when conducting scientific research in ethically sensitive areas,” Yang was quoted as saying in the report on May 9.
The study, published in Nature in March 2022, was led by Miguel Esteban, a researcher with the CAS’ Guangzhou Institute of Biomedicine and Health since 2008. Esteban earned a doctorate in Spain and has worked in the United Kingdom. His research areas are immunology, cancer biology and stem cell biology. Esteban has not responded to a request for comment.
The paper has not been retracted from the journal. A spokesperson for Nature said that for confidentiality reasons they did not comment on the editorial history or review process of specific papers published in the journal. But the spokesperson confirmed they “have not been alerted to any concerns regarding the paper”.
“We expect all papers published in Nature to adhere to our editorial policies and take very seriously any indication of a breach. Ensuring that research published in the Nature Portfolio journals has been conducted to a high ethical standard and reported transparently is of fundamental importance,” the spokesperson said.
“Manuscripts that report experiments involving the use of human embryos and gametes, human embryonic stem cells and related materials, and clinical applications of stem cells must include confirmation that all experiments were performed in accordance with relevant guidelines and regulations.”
In the study, Esteban and his team converted human pluripotent stem cells into eight-cell totipotent embryo-like cells.
Totipotent cells are formed within the first and second division after fertilisation and can develop into any type of cell in the body. Pluripotent cells develop at a later stage, they cannot develop into the placenta, and are more limited in how they develop.
The researchers injected the eight-cell embryo-like cells into the uterus of mice to develop further.
“This innovative technology helped scientists to identify and isolate the target eight-cell embryo-like cells and demonstrate their ‘totipotent’ ability to create the cells involved in generating the placenta in vivo,” the team said in a March 2022 press release.
In a separate press release on the Guangzhou institute’s website, the authors of the study said its content complied with international ethical norms and that all experiments had undergone rigorous ethical review.
China has strengthened ethics oversight on scientific research involving humans in recent years, after Shenzhen biophysicist He Jiankui shocked the world in 2018 by announcing he had created the first gene-edited babies. He was handed a three-year jail term for “illegal medical practices”.
New bioethics guidelines on human-related research were released in March. Medical institutes, colleges and research institutions are now required to set up ethics review committees to conduct life science research involving humans.
A study published last month in Chinese journal Science Bulletin and led by Yang, from the CAS office, found that failure to obtain approval to conduct research from ethics committees was the main reason scientific papers were retracted worldwide.
The study found that 77 per cent of retractions globally and 58 per cent in China were made for this reason. More than 90 per cent of the retracted papers were in the field of biomedical research.
Yang analysed the Retraction Watch Database – which reports on retracted scientific papers – for the study. He found that, from 2000 to 2021, China ranked third in the world after Japan and Germany for the number of papers retracted due to ethical issues.
Of the 92 papers from China retracted in that period, 84 violated ethical review or consensus norms, Yang said.
Researchers at the CAS are required to carry out ethical reviews at the beginning of a major project, according to its official newspaper.
“[We need to] manage the relationship between innovation and ethical governance,” Yang told China Science Daily. “The ultimate goal of ethical governance is to protect innovation.”