Informed consent is defined as “permission granted in full knowledge of the possible consequences, typically that which is given by a patient to a doctor for treatment with knowledge of the possible risks and benefits.”
BMC Public Health, “Research and Publication Ethics to Consider,” BMC Public Health
Most people think of informed consent in the context of surgery, when medical personnel go over a document stating the expected benefits of the surgery and risks (including death). It is important for parents to consider the value of informed consent in less dramatic situations, such as when a doctor recommends antibiotics for an ear infection, medications for obesity, or vaccines to prevent infectious diseases. Barbara Loe Fisher, a tireless advocate for vaccine safety since her son had a severe adverse reaction to a DPT vaccine decades ago, states
“The right to informed consent is an overarching ethical principle in the practice of medicine, for which vaccination should be no exception. We maintain this is a responsible and ethically justifiable position to take in light of the fact that 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.
During COVID, recipients of the ‘vaccine’ (really categorized as gene therapy products) were denied informed consent because the boxes containing vials of COVID ‘vaccines’ initially included a piece of paper designed to mimic the usual package inserts marked “this page intentionally left blank.” There was no information about the vial’s contents, mechanism of action, or expected side effects. Renata Moon, MD, a pediatrician from Washington state, testified she could not possibly give parents information to make informed consent decisions when the package inserts for COVID products were “intentionally blank.” She also testified she had seen a dramatic rise in pediatric myocarditis since COVID shots were introduced. See her dramatic Senate committee testimony here.
Baruch Green, “WATCH: Pediatrician Says ‘Massive Increase’ in Myocarditis, Asks What We Are Injecting in Children,” December 9, 2022, https://vinnews.com/2022/12/09/watch-pediatrician-says-massive-increase-in-myocarditis-asks-what-we-are-injecting-in-children/.
People who were mandated to get COVID injections to keep their livelihoods were not being offered true informed consent. There should not be coercion to get an experimental medical product or lose a job.
In pediatrics, immunizations are the most common intervention for which patients or their parents need to learn about the risks and benefits. There may be an assumption in some practices that parents consent, verbally or in writing, after a statement that “your baby is due for these four shots today.” A full discussion of each vaccine’s purpose, the benefits and potential risks, and the synergistic risks of getting multiple vaccines on the same day is difficult to fit into the seven-to-fifteen-minute office visits typical scheduled in insurance based pediatric practices today.
Kendra Liljenquist, Rachel Hurst, Laura Sotelo Guerra, et al., “Time Spent at Well-Child Care Visits for English- and Spanish-Speaking Parents,” Academic Pediatrics, 23 no. 2 (2023): p. 359-362, doi: https://doi.org/10.1016/j.acap.2022.06.009.
Clinicians administering vaccines to children are required by law to show patients or guardians Vaccine Information Statements edited and updated by the Centers for Disease Control (CDC). Each VIS form has information about how to report adverse events following vaccination to the Vaccine Adverse Events Reporting System but there are no penalties for failure to report.
Ideally, consenting to a medical intervention should be in a time period that allows you to consider your options and decide. Consent for elective surgery should be obtained when surgery is scheduled, not when staff are ready to wheel you into the operating room. Consent for immunizations for your child should be considered before the vaccine is in the syringe.
No type of coercion or bullying or bribing should be a part of the informed consent process, according to the principles of the Nuremburg code.
E. Shuster, “Fifty years later: the significance of the Nuremberg Code,” N Engl J Med, 337 no. 20 (1997): p. 1436-40, doi: 10.1056/nejm199711133372006.
During COVID, peer pressure was used to manipulate children into getting COVID injections. It was unethical to promise pizza parties or field trips in exchange for everyone in the class getting an injection, especially since the shots were only approved for emergency use. The pediatric trials involved small numbers of pediatric patients and were underpowered to detect side effects. There was no convincing data about benefits for pediatric patients nor any long-term data about side effects. Officials driving the bribing strategies exploited the developmental stages of children when peer pressure was a major driving force.
A Washington DC mayor declared that students as young as eleven years old could consent to a COVID injection without the consent of the parent and without the primary care physician knowing. Fortunately, that ill-conceived strategy was overturned in court after lots of work by parents and professionals who pointed out that tweens do not have the cognitive maturity to make abstract decisions about medical interventions.
“Children’s Health Defense Wins Federal District Court Injunction On District of Columbia’s Minor Consent for Vaccinations Act,” press release, March 21, 2022 https://childrenshealthdefense.org/press-release/childrens-health-defense-wins-federal-district-court-injunction-on-district-of-columbias-minor-consent-for-vaccinations-act/.
One pragmatic flaw in the plan to immunize children at school without parental knowledge is this: if the child develops a side effect or a new medical problem, neither the parent nor the doctor will know to consider the immunization as a possible trigger.
Once a vaccine is put on the US National Childhood Immunization Schedule, the pharmaceutical industry is protected from liability if adverse effects occur.
House – Energy and Commerce; Ways and Means | Senate – Labor and Human Resources, H.R.5546 – National Childhood Vaccine Injury Act of 1986, by Rep. Henry A. Waxman. 1986. https://www.congress.gov/bill/99th-congress/house-bill/5546
Parents cannot sue the manufacturers or medical providers even if a child has a severe reaction or dies. Death immediately after vaccines is extremely rare but can happen.
Pharmaceutical industry protection from lawsuits contrasts with product liability rules for other companies. For example, Monsanto was held legally liable for lymphomas caused by Round-up, Ford paid for Pintos that exploded, and the tobacco industry was fined when it was shown that cigarettes cause lung cancer. Too little, too late – but accountability, nonetheless.
In the United States, if your child has a bad reaction to a vaccine, you must go through the National Childhood Vaccine Injury Act of 1986, which leads you to “vaccine court.” I have been there as an expert witness for injured children, and the bar is extremely high to get justice and compensation. Every medical product we prescribe has both known, reported and unknown side effects. Medical professionals must make treatment decisions based on imperfect and incomplete information. Patients and parents must decide whom to trust for medical advice.
Here are five crucial vaccine questions to consider:
You can download and print them to see lots of information about their mechanisms of action, potential serious side effects, the frequency of common side effects and ingredients.
In my pediatric office, we did not follow a “one size fits all” schedule for vaccines. I did not offer vaccines while the child was acutely ill. I considered the family history and the child’s developmental status before making vaccine recommendations. Even then, the family was always free to disagree with me. My staff did not shame or blame parents for their sincerely made decisions.
The other side of the informed consent coin is informed dissent. You may have concerns about heavy metals or ingredients in vaccines. Even doctors like me who try to order the “cleanest” vaccines have limited choices in the marketplace. You may look at the data that unvaccinated children have fewer chronic illnesses and decide to take the risk that your child might get a vaccine preventable disease. For those of you who believe declining or delaying vaccines is irresponsible, remember that people with free will make decisions all the time that are not in their own best interests. People eat poor quality food and don’t exercise enough. Doctors still take care of those people who develop diabetes, heart disease or obesity related to lifestyle choices.
Most parents sincerely try to make good health decisions for their children. I recommend you find a doctor who respects your right to ask questions about your children. For most people, love for their children is such a powerful force that they make huge sacrifices to nurture and raise them. Making medical decisions on a child’s behalf is an important parental responsibility.
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