Vaccine Information Sheet (VIS)
Vaccine information sheets are produced by the CDC. In the US, it is a federal law that the VIS sheet be signed prior to any vaccine administration. It became a requirement with the passing of the National Childhood Vaccine Injury Act of 1986. The VIS sheets purpose is to describe a brief overview of the vaccine, the benefits, and the risks.
It is NOT an informed consent sheet. A parent signs the sheet simply as an acknowledgment that they were informed of the benefits and risks.
There is no Federal requirement for informed consent. VISs are written to fulfill the information requirements of the NCVIA. But because they cover both benefits and risks associated with vaccinations, they provide enough information that anyone reading them should be adequately informed. Some states have informed consent laws, covering either procedural requirements (e.g., whether consent may be oral or must be written) or substantive requirements (e.g., types of information required). Check your state medical consent law to determine if there are any specific informed consent requirements relating to immunization. VISs can be used for informed consent as long as they conform to the appropriate state laws. (bolding mine)
According to an AAP survey regarding consent and immunizations: (bolding mine)
- The majority of pediatricians distribute written information on these vaccines the first time they are administered: 73.0% always distribute written information on the DTP vaccine; 63.8% always do so for MMR; 60.6% always do so for HIB; and 65.4% always do so for OPV.
- The majority of pediatricians also document provision of information in the patient’s record the first time a vaccine is administered. for the DTP vaccine, 61.3% of pediatricians said they always document provision of benefit/risk information, 56% reported always documenting information on the MMR, 53.8% always do so for the HIB vaccine, and for the OPV, 59.1% always do so.
- Two-thirds of the pediatricians reported they never record a parent’s specific verbal consent in the patient’s record the first time a vaccine is administered. For the DTP vaccine, 19.1% of the pediatricians said they always record parent’s specific verbal consent and 15.6% said they sometimes do so. For MMR, 17.1% said they always do and 13.3%, sometimes. For the HIB vaccine, 16.4% said they always record the parent’s verbal consent in the record and 13.8% said they sometimes do so; for OPV, 18.9% always and 13.0% sometimes do so.
One-half of the pediatricians always obtain the parent’s signature as evidence of consent the first time a DTP, MMR, or OPV vaccine is administered; 47.5% do so for the HIB vaccine. Most of the balance of pediatricians said they never do so (39.8% DTP, 43.0% MMR, 46.3% HIB, and 42.9% OPV).
Another AAP survey:
Vaccine administration practices vary as a function of practice setting, practice area and region of the country. For example, pediatricians in group practices (45%) are less likely than pediatricians in hospital/clinic practices (59%) or solo practices (51%) to say they discuss vaccine risks/benefits with every dose of at least six of the seven vaccines (p<.01). Pediatricians practicing in rural areas and those in the Midwest and South are more likely to distribute VIS at every dose than are pediatricians practicing in other areas (70% rural vs. 55% inner city vs. 64% other urban vs. 59% suburban, p<.05) or regions of the country (72% Midwest vs. 68% South vs. 54% West vs. 49% Northeast, p<.001). practitioners in rural areas (65%) also are more likely to document provision of VIS with every dose of each vaccine than are practitioners in urban inner cities (43%), other urban areas (58%) or suburban areas (54%) (p<.01).