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Why does Curi recommend using a COVID vaccine consent form when the FDA, the CDC and most states do not require a signed consent?

While many states do require parental/guardian consent for minors (check with your state for minor requirements to vaccinate), the FDA, the CDC, and individual states have not required adult COVID vaccine recipients to sign a consent form. Nevertheless, they also recognized that some institutions and jurisdictions may have policies that require individuals to sign a consent for these vaccines. Curi acknowledges, supports, and understands the push to distribute the vaccine to as many individuals as possible, but because these vaccines are not fully authorized through the FDA, this puts us all in an untested situation. The vaccine providers facts sheet states the vaccination provider must communicate to the individual receiving the vaccine or their caregiver information consistent with the “Fact Sheet for Recipients and Caregiversprior to the individual receiving the vaccine. Our consent was based on the fact sheet and serves to help validate that recipients were informed and provided the information stated in the recipient’s fact sheet before receiving the vaccine.

Ultimately, it is your practice’s decision whether you will use Curi’s consent form, but this remains our best risk advice. The purpose of these consents is to protect our providers, especially in cases such as the previously expressed concerns about Thrombosis with Thrombocytopenia that caused a short pause in the distribution of the J&J vaccine. While there are both federal and state legislative protections for healthcare workers in regards to the COVID vaccines and other COVID-related conditions, there are caveats that could potentially invalidate these protections if willful negligence could be proven. Should a patient claim they were not informed of the risks associated with the vaccine prior to receipt, the consent form would help serve as proof that the conversation informing the patient of risks did take place and the patient made an informed decision.

We have also designed our consent form to serve as a reminder to the patient to inform the provider if certain contraindications or medical conditions exist, such as immunomodulatory therapies. If your practice does opt out of using a signed consent, we recommend, at a minimum, there be documentation regarding the consent discussion, who was present during the discussion, and that the vaccine fact sheet was provided.

If you would like to discuss further, please contact our Risk Management department.

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All Curi recommendations are based on current CDC criteria at the time of publication. CDC guidance for SARS-CoV-2 infection may, or may not, be adopted by state and local health departments to respond to rapidly changing local circumstances. Providers should always check with their local health department to see if the CDC’s guidance on any given topic has been modified (particularly if more restrictive) from the CDC’s recommended guidelines. Follow this link https://www.cdc.gov/publichealthgateway/healthdirectories/index.html for contact information to your state/local health department. If local recommendations vary from those of the CDC, and you are unsure what recommendations to follow, then it is safer to follow the more restrictive guidelines/recommendations.