Title 21 of the Code of Federal Regulations (CFR) states that Americans in a clinical study must give their written consent to any medical treatment such as vaccination. Since vaccines gain licensure from the FDA by passing through 3 out of 4 safety trials, the side effect ratio is never truly known till the vaccine is used widely by millions. All Americans who receive the vaccine will still be enrolled in surveillance studies (Stage-4) and subject to the CFR protections. According to Title 21:50B of the CFR, informed consent requires candidates for vaccination to be given the right to refuse vaccination; have the right to confidentiality (privacy) that their vaccination data will not be shared with other parties without their consent; and have the right to know if there are any alternatives to vaccination.
