April 17, 2022
According to the 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 medical professional and a patient in which there is an exchange of full risks vs benefits for any given procedure, with patient walking away satisfied that he or she understood what is about to happen.
Now let's look back at this year with the arrival of the experimental vaccines with no sufficient adverse events data to even know the risks we are taking. When it comes to benefits it started with it works, maybe not as much as we thought, maybe this, maybe that but let's all get it because we should, it is our duty. So how does one obtain the 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 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 questions. What we have is not enough.
Many definitions, like pandemics, herd immunity and vaccines, changed in these past few years. I would not be surprised if we wake up one day and informed consent definition also becomes a casualty of this global pandemic agenda. Time will tell. I would watch WHO and other agencies for signaling towards One Health approach in which many of these legal and ethical approaches might not be as transparent.
There is much work to be done going forward. Stay informed, question everything, listen to that inner voice and above all, stay true to your values and always follow the truth. Your heart knows the better way.
Dr. Kat