March 8, 2021
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New Update: COVID-19 Vaccine Consent Forms
 

We have updated the GHA Template COVID-19 Vaccine Eligibility and Consent Form to add a question confirming the recipient’s eligibility to receive the vaccine. This update also includes a new page with the current list of groups eligible to receive the COVID-19 vaccine in Georgia. While you do not need to notate the individual criteria that the patients meet within each category, it is recommended that you have patients attest, either in writing or by a digital appointment scheduling questionnaire, that they fit into one of the eligibility categories. As additional information becomes available or as new vaccines receive emergency use authorization or approval from the FDA, the consent form will likely need to continue to be revised.

 

PLEASE NOTE: There was a misprint in Section 1 of the form that was distributed yesterday. The only change to this version is to correct that error.

As a result of the FDA’s Emergency Use Authorization (EUA) of the Janssen (Johnson & Johnson) COVID-19 Vaccine, GHA has revised its updated Template COVID-19 Vaccine Consent Form with additional information including links to the EUA for the Janssen COVID-19 Vaccine, Janssen EUA Fact Sheet for Recipients and Caregivers, and the Janssen EUA Fact Sheet for Healthcare Providers. As additional information becomes available or as new vaccines receive emergency use authorization or approval from the FDA, the consent form will likely need to be revised.

 

The Georgia Department of Public Health now requires COVID-19 vaccine administrators to report the race and ethnicity of vaccine recipients in the Georgia immunization registry known as GRITS. GHA has updated its Template COVID-19 Vaccine Consent Form to include this information. Please note, there is no requirement that you use this template consent form, but you are required to report to GRITS. As additional information becomes available or as new vaccines receive emergency use authorization or approval from the FDA, the consent form will likely need to be revised.

 

The CDC has published a Pre-Vaccination Checklist for COVID-19 Vaccines. The new Checklist includes a list of screening questions as well as clinical considerations for health care providers when reviewing the screening questions with vaccine recipients. GHA has updated its Template COVID-19 Vaccine Consent Form to include additional screening questions from the CDC Checklist. Please note, there is no requirement that you use this template consent form or that you use the CDC Checklist. Both are being provided as resources only. As additional information becomes available or as new vaccines receive emergency use authorization or approval from the FDA, the consent form will likely need to be revised.

 

As a result of the FDA’s Emergency Use Authorization (EUA) of the Moderna COVID-19 Vaccine, GHA has updated the About This Form page of its Template COVID-19 Vaccine Consent Form with additional information, including links to the EUA for the Moderna COVID-19 Vaccine, the Moderna EUA Fact Sheet for Recipients and Caregivers, and the Moderna EUA Fact Sheet for Healthcare Providers. As additional vaccines receive emergency use authorization or approval from the FDA, the consent form will likely need to be revised.

 

In order to help hospitals prepare for the administration of the COVID-19 vaccine, GHA has created a template COVID-19 Vaccine Consent Form.* This template is based on a typical influenza vaccine consent form modified to reflect the newly available information from the Food and Drug Administration’s (FDA's) Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, the EUA Fact Sheet for Recipients and Caregivers, and the EUA Fact Sheet for Healthcare Providers. During the first phase of vaccine administration, hospitals may need to add fields specific to their vaccination implementation and tracking process. For later phases, you will also need to collect insurance or other payment information.

GHA has also created a template COVID-19 Vaccine Refusal Acknowledgement Form for your staff who may decline to receive the vaccine.

Prior to finalizing either the vaccine consent form or the vaccine refusal acknowledgement form, GHA recommends hospitals review them with their clinical experts, legal counsel and risk managers. These forms are being provided for informational purposes only and are not legal advice. There is no requirement to use the GHA templates, and some facilities have already developed or are working on developing their own forms. As additional vaccines receive emergency use authorization or approval from the FDA, the consent form will likely need to be revised.

If you have questions about the template COVID-19 Vaccine Consent Form or the state’s COVID-19 vaccine distribution plan, please contact COVID19@gha.org.

*The FDA does not require a recipient’s informed consent for the administration of an EUA product like the COVID-19 vaccine. For that reason, this type of form could alternatively be used as a “screening and acknowledgment form” rather than a “consent form.”