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The seven couples involved in the CRISPR babies experiment in China were misinformed about what it involved, were pressured to take part and faced severe financial penalties if they withdrew after getting IVF, according to a damning analysis of the consent process.

The project would have been unethical even if the aim wasn’t to create the first ever gene-edited children, says bioethicist David Shaw at the University of Basel in Switzerland, who carried out the analysis. “It’s just wrong in terms of research ethics,” he says.

In November 2018, biophysicist He Jiankui stunned the world when he revealed that two CRISPR-edited children had been born in China to one woman, with another woman pregnant with a gene-edited fetus. From the start, it was clear there were numerous ethical concerns about what had been done.

For instance, tests of the edited embryos revealed several problems, but the team implanted them anyway. He’s justification for the trial was to make the children resistant to HIV, but it is likely to have failed to achieve this.

Last month, He was sentenced to three years in jail for forging ethical review materials, violating research regulations and causing harm to society. However, the brief announcement by the Chinese state news agency Xinhua gave few details.

Meanwhile, Shaw has analysed the consent forms and related documents, which were available for a time in 2018 on the team’s website complete with English translations. “Ethically, things are even worse than they initially appeared,” he writes in his paper.

The consent form given to participants began by saying the project was an AIDS vaccine trial, and only later described its real aim, and then in a misleading, jargon-filled way. For instance, it said the babies would be “naturally immunized” against HIV.

The offer of free IVF to would-be parents also put considerable pressure on them to take part, says Shaw. The form told participants that if they withdrew from the study after an embryo was implanted, they would be liable for costs and fines that could exceed 380,000 yuan (£42,000).

The form also states that the project team wouldn’t be responsible if the children had any unintended adverse mutations. As this is a known risk of CRISPR gene editing, Shaw calls the move “an appalling abdication of responsibility” in his paper.

Shaw thinks the team realised there were problems with the consent form, as it produced a supplementary version. However, the only major omission it addressed was the failure of the first form to say that any children born would be followed up for at least 18 years.

“The participants in this study were clearly misinformed about the study’s purpose,” concludes Shaw.

According to He, all the participants were fully informed. “These were volunteers. They all have a good education background. They had a lot of information about HIV drugs and other approaches,” . “They already understood quite well about the gene editing technology and the potential effects and benefits.”

The ethics application form that was supposedly submitted to an ethics committee and approved before the project began is more honest about the project’s aims, says Shaw. However, according to the authorities in China, that approval was never given.

Unusually, this form also makes big claims about the project’s importance. “This is going to be a great science and medicine achievement ever since the IVF technology which was awarded the Nobel Prize in 2010,” it states.

Shaw’s conclusions seem reasonable, says Peters Mills of the Nuffield Council on Bioethics in the UK. Any experimental procedure should be lawful and follow relevant guidelines. “This case apparently failed to meet these standards with uncommon extravagance, which is sufficient for those responsible to deserve grave sanctions,” says Mills.