Informed Consent

“Informed consent” is the process by which a patient (or parent, for their minor) learns about and understands the purpose, benefits, and potential risks of a medical or surgical intervention, including clinical trials, and then agrees to receive the treatment or participate in the trial. Giving consent should be wholly voluntary and free from coercion, express or implied.

When it comes to vaccines for children, federal law requires that prior to administering a vaccine, the patient or parent be given a “vaccine information sheet” (VIS). VIS’s are written to fulfill the information requirements of the National Childhood Vaccine Injury Act, NOT as informed consent forms.[1] Your right to informed consent prior to a vaccine being administered is regulated by Oregon law.

ORS §677.097 is the Oregon statute that defines what a doctor or doctor’s assistant must explain in order to obtain informed consent.

1) “In order to obtain the informed consent of a patient, a physician or physician assistant shall explain the following:

(a) In general terms the procedure or treatment to be undertaken;

(b) That there may be alternative procedures or methods of treatment, if any; and

The informed consent statute in Oregon puts a low burden on the doctor to explain the risks and procedures involved only in general terms and ask if the patient wants more detailed information, and then shifts the burden to the patient or parent to get more information if desired. The statute further states:

2) “After giving the explanation specified in subsection (1) of this section, the physician or physician assistant shall ask the patient if the patient wants a more detailed explanation. If the patient requests further explanation, the physician or physician assistant shall disclose in substantial detail the procedure, the viable alternatives and the material risks unless to do so would be materially detrimental to the patient. In determining that further explanation would be materially detrimental the physician or physician assistant shall give due consideration to the standards of practice of reasonable medical or podiatric practitioners in the same or a similar community under the same or similar circumstances.”

A small survey showed that few doctors or doctor’s assistants ask either patients or parents of children getting vaccines if they want a more detailed explanation of the risks involved in vaccines and rely upon the VIS, which is NOT intended to fulfill the requirements of obtaining informed consent. The VIS information is lacking the drug risk information from the manufacturer’s product inserts including: ingredients, (adjuvants, excipients, and allergens), contraindications, severe adverse reactions, safety testing results, and effectiveness data.

There are no safety trials on the cumulative effect of the aggressive US vaccine schedule on developing children. The vaccine schedule has expanded from 25 doses in 1986 to 72 doses in 2019. According to a 2013 report by the Institute of Medicine, “Thus, key elements of the entire schedule – the number, frequency, timing, order and age at administration of vaccines – have not been systematically examined in research studies.”[2]

Oregonians have the legal right to opt-out of any mandated vaccine based on medical, religious, or philosophical exemptions and still attend schools, daycares, and colleges. Oregonians for Medical Freedom is dedicated to preserving the right to informed consent for vaccines and opposes any and all legislation that would eliminate that right.

[1] https://www.cdc.gov/vaccines/hcp/vis/about/vis-faqs.html

[2] https://www.nap.edu/catalog/13563/the-childhood-immunization-schedule-and-safety-stakeholder-concerns-scientific-evidence