By Norma Erickson
Throughout the 20th century, countless medical consumers have battled to obtain the right to informed consent. Although the U.S. Constitution does not specifically address the issue, multiple court cases have upheld the premise that the constitutionally guaranteed right to privacy insures that people are protected from governmental interference when deciding private matters, such as when they make decisions about accepting or refusing medical care.1 Every medical consumer now has the legal right to participate in their health care decisions via the doctrine of informed consent. It is our responsibility to preserve this right for future generations.
What is informed consent?
According to the National Institutes of Health2 your doctor must disclose and discuss the following in order to comply with informed consent laws:
- Your health problem and the reason for the treatment
- What happens during the treatment
- The risks of the treatment and how likely they are to occur
- How likely the treatment is to work
- Other options for treating your health problem
- Unknown risks or possible side effects that may happen later
- If treatment is needed now or can wait
Ask yourself, when was the last time a vaccine-provider discussed the potential side-effects of a vaccine or alternative options with you prior to the administration of the vaccine? If you have allergies, did they discuss the possibility of an allergic reaction to any components of the vaccine being administered? Did they discuss efficacy of the vaccine?
According to the National Institutes of Health web site, 4 not only is your doctor required to discuss the seven topics above; they are required to obtain written consent for the following:
- Most surgeries, even when they are not done in the hospital
- Other advanced or complex medical tests and procedures.
- Radiation or chemotherapy to treat cancer
- Most vaccines
- Some blood tests, such as HIV testing (need for written consent varies by state)
Only after all pertinent facts have been discussed to the point where you understand them, are you able to exercise your right to informed consent. In order to do so, you must be mentally competent to make an informed decision and have attained the legal age of consent. Only then are the laws of informed consent satisfied.
How did citizens obtain the right to informed consent?
Many people assume informed consent was achieved after the Nuremberg trials as a direct response to the atrocities committed in the name of research. Actually, the battle was being waged much earlier.
In a 1905 opinion on the Parmelia Davis2 (uterus and ovaries were removed without her permission) case, the Supreme Court declared that Americans’ rights as free citizens prohibited:
“a physician or surgeon, however skillful or eminent…to violate without permission the bodily integrity of his patient…and [to operate] on him without his consent or knowledge.”
In a 1914 Supreme Court decision involving a patient who had consented to only a portion of the surgery which was actually performed, (Mary Schloendorff) Justice Benjamin Cardozo3 added,
“Every human being of adult years and sound mind has the right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault, for which he is liable in damages, except in cases of emergency where the patient is unconscious, and where it is necessary to operate before consent can be obtained”
In spite of these rulings, it was not until 1957 that patients acquired the right to be told not only what the doctor was going to do, but also that action’s possible positive and negative effects. In 1957, the California Court of Appeals3 ruled for plaintiff Martin Salgo (left paralyzed following a hospital diagnostic procedure) writing:
“A physician violates his duty to his patient and subjects himself to liability if he withholds any facts which are necessary to form the basis of an intelligent consent by the patient to the proposed treatment.”
How does this apply to vaccines?
Vaccines are a medical intervention. As with any medical procedure, there are risks involved to certain individuals. Under the informed consent doctrine, you have a right to know these risks and alternative treatments prior to granting your consent. Remember, informed consent is the law – not simply an option.
According to the NIH, you have the right to refuse any medical procedure if you are able to understand your health condition, your treatment options, and the risks and benefits of each option. Your doctor or other health care provider may tell you they do not think this is the best choice for you. But, your health care providers should not try to force you to have a treatment you do not want to have.
However, all 50 states mandate (require) vaccinations for daycare, pre-school, school attendance and/or as a condition of employment. All 50 states also allow exemptions from vaccination for one or more of the following: medical, religious, or philosophical reasons. The rules for obtaining these exemptions vary widely from state to state. Whether you realize it or not – this is an intrusion on your right to informed consent.
Many states, like Oregon, are trying to further erode the concept of informed consent by making it more difficult for parents to exercise their rights under the guise of vaccine education. Will this ‘education’ include all of the information you need to make an informed choice?
According to the basic principles of informed consent, the only time government entities should be allowed to interfere with your right to exercise informed consent is during a bona fide public health emergency, a life threatening medical emergency, the patient’s incompetence, or if you waive your rights.
How can medical consumers retain their right to informed consent?
It has taken decades of painful litigation to force the medical community to allow people a voice in their own healthcare decisions. Almost as soon as that right was assured, lobbying began to try return to the ‘more comfortable’ status quo. Should your right to informed consent be legislated away regarding vaccines and vaccination policies, you can rest assured your rights to informed consent regarding other medical procedures and practices will follow.
What can you do to protect your rights? Political activist, author and healthcare rights advocate, Catherine J. Frompovich puts forth the following suggestions:
- Introduce language to amend any current laws/regulations restricting informed choice that exist in any state.
- Make sure any pending legislation includes language preserving the right to informed consent.
- In the interest of public health and safety, introduce a Vaccine/Vaccination Education/Information Bill in all 50 states, requiring the following:
(1) Any medical consumer over the age of consent must receive Vaccine/Vaccination Information containing the following data:
(a) A complete list of ingredients in each vaccine, including excipients, adjuvants and antigens; and
(b) A complete list of potential adverse reactions as listed on vaccine package inserts for each vaccine proposed for administration; and
(c) Complete instructions on how to file adverse reaction reports to VAERS (Vaccine Adverse Event Reporting System);
(2) Require all cases adjudicated within the Vaccine Injury Compensation Program be made available for public review under John/Jane Doe status
The right to fully informed consent did not simply materialize out of thin air. The battle to guarantee this right was long and painful. The right to informed consent was gained at the expense of many people’s health and/or lives.
Rights come with responsibilities. It is our responsibility to make sure the sacrifices of others were not made in vain. It is our responsibility to preserve the right to fully informed consent for future generations. The alternative is unthinkable.
- History and Development of the Doctrine of Informed Consent; Hana Osman, MSWW
- Informed Consent; Medline Plus, National Institutes of Health
- Katz J. The Silent World of Doctor and Patient. Baltimore: Johns Hopkins University Press; 2002:2.
- Spock, Feminists, and the Fight for Participatory Medicine; Michael L. Millenson