Years ago I embarked on my dream career which came to me by what felt as a sort of divine cosmic accident. I was offered a job as coordinator for a local hospital Institutional Review Board. At the time, I hardly knew what an IRB was, and I had barely ever heard of clinical trials, but soon, it became a passion of mine, and for the next ten years I worked organizing and coordinating the review board that oversaw medical research on human subjects.
As part of my job, I came to appreciate and understand a bit of history that necessitated the need for an Institutional Review Board. After the humanitarian disaster that came out of Nazi Germany in the 1930’s and ‘40’s, and the ensuing trials at Nuremberg wherein many of the research scientists were found guilty of crimes against humanity and subsequently executed for their many offenses, it was apparent that humanity was left reeling, groping in the dark wondering how in the world did we allow this to happen under our collective noses? Good men and women at the time were left pondering that glaring question wondering how to prevent such atrocities from ever happening again.
The answer came in what became known as Informed Consent. Ever since the atrocities of Nuremberg, all subsequent research done on human subjects must adhere to strict oversight and guidance. From that point in history up to the present day, all research on humans must be conducted only on willing volunteers, who are to be fully informed of the nature of the research, the implications of the research, and it must be emphatically stated that no person can ever be coerced or forced against their will to participate in clinical research trials. All volunteers must sign an approved Informed Consent Form giving their full permission to willingly participate as a subject of human medical research.
What we see happening in the world today is of grave concern to me as someone who worked in the field of medical research and who understands the importance of informed consent.
Early last year, we had experimental vaccines brought forward through “Emergency Use” procedure, effectively bypassing the Nuremberg code of ethics for informed consent. Millions of people have already taken an experimental vaccine without ever being presented the facts about the experimental nature of the vaccine, nor even a hint that the vaccine is even experimental at all. To my knowledge the vaccines have only been authorized for emergency use, but are not yet approved by the FDA.
At a minimum, every person receiving an experimental vaccine should be provided with a standardized Informed Consent Form which has been approved by an authorized Institutional Review Board, outlining the nature of the experiment, all possible or known side effects, resources they can contact for injury or additional information, and their rights as human subjects. This to my knowledge has not been done!
To make matters worse, right now, we have certain state governors (Michigan for example) coercing their citizens to take an experimental vaccine without signing informed consent and being advised of their rights. This goes directly against the Nuremberg code of ethics! Per Nuremberg, no one is to be coerced into participating in any kind of experimental procedure without being fully informed of the entire nature of what they are participating in, and fully understanding their rights under the law.
Everyone has the the right to participate OR refuse to participate in research. Anyone who threatens, coerces, intimidates or shames others to force them to participate in human research is violating the Nuremberg code and may be guilty of crimes against humanity. This is a very serious issue and we should all be concerned for our neighbors to have the right to participate or to refuse to volunteer as a human subject without reprisal.
There seems to be a concerted effort not only to disregard the Informed Consent, but to ridicule those who are expressing concern that these protective measures have not been heeded. Right now, people are being labeled as “conspiracy theorists” or “anti-vaccine” simply for asking questions and wanting to have answers before receiving an experimental injection. This is unfortunate. Informed consent is a legitimate stop gap measure put in place to protect people’s inherent rights and it is being systematically ignored. Fully informed consent under the Nuremberg code of ethics simply means you have been presented all of the facts about the procedure, you understand your rights under the law and the health implications of what you are doing, and you willingly volunteer under no threat of coercion to participate. Being willing to participate also includes having the right to refuse or to decline participation in clinical trials research on human subjects.
The fact that the global pandemic warranted foisting an emergency authorized vaccine on the general population does not negate the fact that people still have rights under the law. No global pandemic, no matter how severe, should ever be used as a means to disregard basic human rights of informed consent.
People have the right to know the exact nature of an experimental procedure, the possible side effects, exactly what they are agreeing to, and that they have the right to refuse to participate with no threat of reprisal of any kind, such as the threat of losing their job or being declined admission to college, or delaying their state being reopened for business.
All people should be given every opportunity to view and understand with full knowledge an approved Informed Consent Form which outlines their inherent rights as human subjects. Informed Consent is about respecting the rights of human subjects involved in research. The lessons of Nuremberg should never be forgotten. Voluntary consent is one important step that will help keep humanity from falling back into the abyss of human atrocity borne at the hands of madmen. We must never allow the likes of Nazi Dr. Joseph Mengele to ever have free rein to abuse the rights of citizens on this earth ever again.
It is time for the global community to understand their rights and demand that as a research participant they be presented with a fully disclosed, IRB approved Informed Consent Form prior to receiving experimental vaccines. It is our right to be informed and to have our rights protected, including the right to say no.
As people, we must have our rights protected if and when we willingly choose to volunteer as a participant in experimental medical research on human subjects.