Informed Consent
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Biologics R Vaccines: Beware of “Informed Consent”
Published July 23, 2017 | Ethics, Informed Consent
If
you do not want vaccines to be given to you, your child or family
member who has entrusted you to make medical decisions for them, you
have the legal right to sign a statement on the written consent form
refusing any type of vaccine.
According to the U.S. Food and Drug Administration (FDA):
Biological products, or biologics are medical products. Many biologics are made from a variety of natural sources (human, animal or microorganism). Like drugs, some biologics are intended to treat diseases and medical conditions. Other biologics are used to prevent or diagnose diseases. Examples of biological products include vaccines, blood and blood products for transfusion and/or manufacturing into other products, allergenic extracts, which are used for both diagnosis and treatment (for example, allergy shots), human cells and tissues used for transplantation (for example, tendons, ligaments and bone), gene therapies, cellular therapies and tests to screen potential blood donors for infectious agents such as HIV.1Vaccines are biologics, but new consent forms do not explicitly state this. If you provide your consent for you or your child to receive biologics in a hospital, doctor’s office or other facility that administers pharmaceutical products, you are giving medical personnel permission to administer any vaccines they deem necessary while you are under their care. If you’ve consented to biologics and it is “flu season,” f0r example, and you are receiving medical care, you may be given the influenza vaccine without specifically being asked or informed beforehand, even if you happen to be under anesthesia.2
If you do not want vaccines to be given to you, your child or a family member who has entrusted you with making medical decisions for them, you have the legal right to sign a statement on the written consent form refusing any type of vaccine. Request a copy of your signed statement on the consent form and keep it with you.
It is also a good idea to advise the health care professionals treating you, your child or family member that no vaccines are to be administered in that particular health care setting. Often, informed consent forms remain at the reception area front desk of a medical facility and are not shared with attending medical personnel, leading to possible misunderstandings and vaccination without your informed consent. It is particularly important in the newborn nursery, where hepatitis B vaccinations are routinely given to infants within 12 to 24 hours of birth or just before discharge.
Vaccination is a Medical Intervention
People who administer vaccinations tend to downplay the importance of obtaining informed consent from the patient or family member responsible for making medical decisions for the patient. That is because public health officials and medical trade associations take the position that vaccines are generally safe for everyone,3 4 even though it is clear that there are known and unknown biological risk factors that make some individuals more susceptible to being harmed by vaccinations.5Regardless of what a physician’s beliefs are about the benefits and risks of vaccination, it is important to understand that informed consent is required for all medical interventions that carry a risk of harm, such as surgery, and it should be no different for vaccination because vaccination does, in fact, involve the use of pharmaceutical products that carry the risk of injury or death.
The National Vaccine Information Center (NVIC) maintains:
Vaccination is subject to the same medical informed consent ethic that guides modern medicine today because vaccination is a medical intervention performed on a healthy person that has the inherent ability to result in the injury or death of that healthy person. In consideration of the fact that there can be no guarantee that the deliberate introduction of killed or live microorganisms into the body of a healthy person will not compromise the health or cause the death of that person either immediately or in the future; and with very few predictors having been identified by medical science to give advance warning that injury or death may occur; and with no guarantee that the vaccine will indeed protect the person from contracting a disease; and in the absence of adequate scientific knowledge of the way vaccines singly or in combination act in the human body at the cellular and molecular level, vaccination is a medical procedure that could reasonably be termed as experimental each time it is performed on a healthy individual.6The concept of medical informed consent stems from the ethical principle of autonomy, and patients have the legal right to be fully informed about the benefits, risks and failures of a physician-recommended medical procedure prior to making an informed and voluntary decision about whether or not to accept the risks. Like freedom of thought, speech, conscience and religious belief, informed consent to medical risk taking is recognized internationally as a human right.7
Nobody, including your physician, has the right to coerce you into agreeing to a medical intervention, such as vaccination, which could result in injury or death.
You have the legal right and responsibility to exercise informed consent by carefully reading written informed consent forms prior to any medical procedure, including receipt of biologics (vaccines). Informed consent is protection against violation of human rights in the medical system.
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