this post was submitted on 25 Aug 2024
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A Boring Dystopia
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Yeah theres a lot here that stinks, I'm going to have to find more sources on it.
This clearly violates informed consent, and a whole bunch of study related laws, and laws involving patient care and risks of invasive procedure.
She had to agree to the surgery to remove it at some point, and it could not have been in informed consent documentation, because she could have revoked that agreement before the surgery.
I doubt this story. I really doubt this.
However, I don't know shit about fuck about Australian law.
One relevant detail is that this was not a self contained device, it was for monitoring likelihood of seizures and had an external wireless interface. So my guess (this is pure speculation) on what happened is, the company owned the monitoring device, and the signals from the in-brain device were proprietary and encrypted. They couldn't force her to have surgery but they could take back the external interface which was their property, and without that the in-brain device did nothing. Then the patient agreed to surgery because there was no further benefit to keeping it in her head and probably greater health risks to doing so.
I'm sure if she revoked the informed consent they never would have done the implant to begin with. It's an experimental procedure so you kind of need to agree to being expiramented on to participate.
You can revoke your informed consent agreement at any time, including after a study has concluded, though it doesn't usually do you much good after it's done. it specifically means that you no longer agree to understanding the risks and benefits.
I found a paper that someone wrote on the subject and it appears that the woman did consent to having it removed, though she ultimately did wish she could have kept it. From the OPs article, it sounds like she was forced to have the craniotomy against her will which isn't the case.
https://www.brainstimjrnl.com/article/S1935-861X(23)01910-1/fulltext
That checks out. Thank you.