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Thursday, November 21, 2019

Human Participants In Experimentation On The Brain? They Better Be Treated Well.

Nov 21, 2019 Elizabeth Fernandez



The MRI of a patient suffering from Dystonia, who received implants within the brain.  UNIVERSAL IMAGES GROUP VIA GETTY IMAGES


Some diseases of the brain are incredibly hard to treat. Parkinson’s Disease. Alzheimer’s. Severe depression. Cutting edge neurotechnologies may help people suffering from these diseases. Sometimes this comes in the form of a brain implant - sometimes, electroconvulsive therapy. These therapies involve exerting control over the central nervous system. Developing these therapies, however, involves human experimentation. Because of this, the National Institutes of Health Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) Initiative not only focuses on developing new technologies but also on the ethics of these technologies - particularly, how the participants of the studies will be affected. BRAIN’s working group recently developed a set of ethical guidelines, some of which have not been widely considered before. 
Neurotechnologies that control the central nervous system can come in various forms. Invasive devices can be implanted within the brain, under the skull or below the dura. The most common of these is DBS, or deep brain stimulation. In this treatment, an electrode is placed within the brain. This can help a patient, even if they had previously not responded to other treatments, such as medication. DBS can treat things such as Parkinson’s disease, epilepsy, and obsessive-compulsive disorder, and is being investigated for the treatment of Alzheimer’s, obesity, and chronic pain. Other types of neurotechnologies can help with prostheses or spinal cord injuries. In addition, there are various types of noninvasive procedures, such as electric, magnetic or sonic stimulation of the brain. 
“Cutting-edge science requires cutting-edge ethics,” said Khara Ramos, Ph.D., who co-authored the report and who is the Director of Neuroethics at the National Institute of Neurological Disorders and Stroke. In order for research to move forward, research participants are needed. Three ethical standards were outlined in the report that protect these participants. 
Firstly, the risks and benefits must be weighted. The benefit of the new technology must be larger than the risk to the individual participants. Experimentation involves some risk, and these risks should be minimized. The surgery itself could lead to hemorrhage, a seizure or infection. The implant could move. There is a privacy risk if people don’t fully understand what data is being recorded. And there is even a risk that the participant’s personality may be altered by the implant. Some of these changes may be permanent. 
This brings us to the second ethical point: informed consent. Patients need to understand what the treatment entails and what the risks are. They should know the alternatives and should not be pressured to participate. This becomes complicated when the patient cannot consent because of an inability to communicate. “Because neural device research affects the brain in predictable and unpredictable ways, facilitating informed consent by considering participants’ values, interests, and preferences may be especially important,” says Ramos and co-authors.
A patient undergoes surgery to implant an electrode in the brain as a treatment for Parkinson's ... [+]UNIVERSAL IMAGES GROUP VIA GETTY IMAGES

The final ethical point, and one that has not been investigated in depth before, is what happens after the trial is over? Participants often think that the cost of their care after the trial is over will be covered, but this is not always the case. Imagine if the battery of the implant needs to be replaced after the trial. Who pays? What if the patient is benefiting from the implant? Who covers the cost of treatment after the trial ends? Health insurance many times will not cover expenses like this, so the authors encourage researchers to plan for care of the participants even after the trial is completed. 

“Such studies are only possible because research participants generously contribute,” says Ramos and co-authors. Their interests should be guarded, both during and after the trial.
https://www.forbes.com/sites/fernandezelizabeth/2019/11/21/human-participants-in-experimentation-on-the-brain-they-better-be-treated-well/#61302c2d2d55

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