Why is He Jiankui in real trouble with justice in China?: Consent form and Harmonicare Hospital statement

He Jiankui, the scientist who achieved notoriety with the gene-edited babies scandal, may be facing an unusually harsh punishment in China. Even the death penalty seems to be in the cards. The most troublesome aspect of his misadventure appears to be that which relates to corruption charges. He Jiankui allegedly misled the participants in the trial. He Jiankui knowingly and recklessly misrepresented his work to them as an “aids-vaccine development project”, as stated in the opening paragraph of the consent form pasted below. Moreover, He Jiankui stated at the Hong Kong summit that he personally engaged the volunteer patients through the informed consent process. He claimed he did this with the help of another professor, possibly Michael Deem from Rice University (He Jiankui’s  doctoral adviser). The consent document that he used describes the procedure in a language that is incomprehensible for anyone not seriously involved with the subject.  Neither He Jiankui nor his collaborator(s) appear to have alerted the patients about possible off-target effects, or about the fact that gene editing was not an approved procedure, still entangled with ethical and methodological controversy.

 

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Opening paragraph of He Jiankui’s  Informed Consent Form. Source:  南方科技大学

Furthermore, He Jiankui and his collaborators misled the volunteer patients in other ways.  The “consent form” the patients were asked to sign was in fact a “business form”, the kind that companies would use for subcontracting. The section about possible risks said nothing about off-target effects or the consequences of methodological errors,  focusing instead on excluding He Jiankui and his coworkers of any liability.

Source: http://webcache.googleusercontent.com/search?q=cache:http://www.sustc-genome.org.cn/source/pdf/Informed-consent-women-English.pdf

Furthermore, He Jiankui appears to have deceived his own institution. He work in the utmost secrecy and did not tell the Southern University of Science and Technology in Shenzhen [ 南方科技大学] about the experiment, although SUSTC is clearly stated to be the funding source in the Informed Consent Form (see opening paragraph above).  Even more seriously, He Jiankui claimed that he received ethical approval from Shenzhen Harmonicare Hospital. However, in a statement, the hospital informs the public that the Medical Ethics Committee never met to discuss He Jiankui’s project, and that the signatures on the ethical approval form “are suspected to be forged”.

 

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Opening page in the Statement by Harmonicare Hospital, Shenzhen related to the claims by He Jiankui. This is possibly the most incriminating document in He Jiankui’s prosecution.

Source: http://asia.blob.euroland.com/press-releases-attachments/1108747/HKEX-EPS_20181127_003332422-0.PDF

While He Jiankui was working in secrecy, he was also building a huge public-relations campaign, creating YouTube videos where he described his scientific adventure while dreaming about his place in history…

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