This is, as @CT_Bergstrom says, shocking. Not only does it further call into question the results of the study, it also raises serious medical and research ethics problems. 1/ https://twitter.com/stephaniemlee/status/1253737601292316672

Most importantly, this undermines the informed consent from research participants. Under the Common Rule, they must be given a "description of any benefits to the subject or to others that may reasonably be expected from the research." 45 CFR § 46.116(b)(3). 2/

Telling participants that they could "return to work without fear" if they tested negative misstates the benfits from the test. So their consent may not have been properly informed. 3/

Similarly, participants must be given a "description of the procedures to be followed," 45 CFR § 46.116(b)(1) and "FDA approved" is a material misstatement about the testing procedures. 4/

So this is a potential Common Rule violation, which is not a good look. In theory, it coud lead to loss of federal funding for research at the affected institution, although that's very unlikely, especially if they take action to cure the harm as best possible. 5/

What does that action look like? First, this seems almost certainly to be an incident that woud require the investigators to report to the IRB that there was a breach of the approved study protocol. 6/

Any competent IRB would then want to investigate who saw the message, and what other non-IRB-approved communications to potential and actual participants there were. 7/

This investigation would pretty much have to include the other studies being conducted by the same investigators with similar protocols, including the LA study and others in the pipeline. 8/

To cure the harm from misleading the participants in this study, the IRB probably needs to have the investigators send them a follow-up communication specifically repudiating the false claims in the emails. 9/

This makes it much harder for the results of the research to be published. It's not just that the results might be wrong (although there is that), but that reputable journals refuse to publish research conducted illegally or unethically. 10/

The Stanford PI, Jay Bhattacharya, has argued that the email "was sent out without my permission or my knowledge or the permission of the research team." I'm not so sure that this means it doesn't count. 11/

Bhattacharaya is married to Catherine Su, the email's author. In many legal contexts, this would be enough for her actions to be attributed to him. (If he wanted to avoid that, argument goes, he could just have asked her not to email about his study without checking with him.)12/

Moreover, given the close relationship (and her , this could also raise an apparent-authority argument. People reading her email might reasonably but mistakenly think that it was an approved part of the study. 13/

And most importantly, ethical researchers can't ignore misinformation about their research shared with potential participants, even if they themselves weren't responsible for it. They can't leave participants' known false beliefs about research benefits uncorrected. 14/

Finally, Su is herself a doctor. Sending people false statements about the FDA-approval status and health benefits of a procedure in order to enroll them in a study conducted by a close family member is potentially of interest to the state medical-licensing authorities. 15/

In short, this email is an ethical disaster. 16/16