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According to Wikipedia, informed consent is ‘a principle in medical ethics and medical law that a patient should have sufficient information before making their own free decisions about their medical care.’ According to the NIH: ‘Informed consent is the process in which a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention. The patient must be competent to make a voluntary decision about whether to undergo the procedure or intervention. Informed consent is both an ethical and legal obligation of medical practitioners in the US and originates from the patient's right to direct what happens to their body.’

Essentially, informed consent is a conversation between a medical professional and patient in which there is an exchange of full risks vs. benefits for any given procedure, with the patient walking away satisfied that he or she understood what is about to happen.

Now, let's look back at the past year, with the arrival of the experimental vaccines that lacked sufficient adverse events data to even know the risks we are taking. Regarding benefits, the narrative began with: “It works...well, maybe not as much as we thought...but everyone should get it because...we should; it’s our duty.” 

How does one obtain true legal and ethical informed consent? In my opinion, it is impossible because we have not met the threshold of what informed consent is. We do not have a full set of data to assess the risk. We definitely do not have long term data to tell us what might happen down the line. What we have is many people in VAERS or Yellow Card databases who are looking for answers. What we have are a multitude of questions. What we have is simply not enough.

Many definitions, including those for pandemic, herd immunity and vaccine, changed during the past few years. I would not be surprised if we were to wake up one day and find that the definition for informed consent has also become a casualty of this global pandemic agenda. Time will tell. I suggest watching WHO and other agencies for signals that point toward their One Health approach — one in which the transformation and degradation of these legal and ethical tenets are unlikely to be transparent.

There is much work to be done going forward. Stay informed, question everything, listen to that inner voice and stay true to your values. Always follow the truth. Your heart knows the better way.

Dr. Kat