Virginia Freedom Keepers is a grassroots organization that rallies communities and empowers individuals to be active guardians of their right to informed consent.
Informed consent is a patient-to-provider discussion regarding the risks, benefits, and alternatives to any given procedure or intervention followed by the right to decline said medical product or procedure without fear of repercussion. Although often overlooked, informed consent involves having a full picture of how a medical product will affect you as a unique individual with the recognition that not all of us will react the same to a given product or environment. The bio-individuality of each person is contributed to by background, ethnicity, diet, environmental exposure and endless other attributes. This unique dynamic that creates the individual does not suspend for a medical product. No medical product is one size fits all and will thus have a unique particular experience for each person.
The American Medical Association (AMA) is the largest association of medical professionals that works to create standardized ethics, care and the betterment of public health. The AMA formally declares in their medical ethics opinion that informed consent is fundamental in areas of law and ethics and that “Patients have the right to receive information and ask questions about recommended treatments so that they can make well-considered decisions about care.”
Informed consent per the American Medical Association
“The process of informed consent occurs when communication between a patient and physician results in the patient’s authorization or agreement to undergo a specific medical intervention. In seeking a patient’s informed consent (or the consent of the patient’s surrogate if the patient lacks decision-making capacity or declines to participate in making decisions), physicians should:
Patient bill of rights and vis
Standardized informed consent procedures regarding recommended vaccinations was established in the National Vaccine Injury Act. This Act resulted in common handouts, or the Vaccine Information Statement (VIS) most parents are familiar with given at routine pediatric appointments. According to the Centers for Disease Control “A VIS or Vaccine Information Statement is a document, produced by CDC, that informs vaccine recipients – or their parents or legal representatives – about the benefits and risks of a vaccine they are receiving.” The VIS provides generic information about commonly acknowledged reactions. The VIS statements are required to contain concise understandable information and must also include information about the Vaccine Injury Compensation program.
The guidance from the AMA , along with other definitions of informed consent, leave the standard VIS lacking to meet the basic criteria that is ethically necessary for a patient to make a fully informed choice. The standardized VIS offers vague information on the most commonly acknowledged reactions while leaving out many other serious reported adverse reactions, and is not clear and direct on essential information.
Virginia freedom keepers guidelines for informed consent
In order to provide true informed consent we believe it is imperative to disclose the following;
Informed consent. (n.d.). Retrieved February 18, 2021, from https://www.ama-assn.org/delivering-care/ethics/informed-consent
TITLE 42- The Public Health and Welfare (1987, December 27). Retrieved from
Patient bill of rights (n.d.). Retrieved February 18, 2021 from https://clinicalcenter.nih.gov/participate/pat
Electronic supporting for public health- Vaccine Adverse Event Reporting System. Retrieved February 24, 2021 from https://digital.ahrq.gov/sites/default/files/docs/publication/r18hs017045-lazarus-final-report