Consent Form and VIS
The consent form is the most important document for the program and may be the only method you have to communicate in detail with families. It is recommended that all the information needed to obtain consent be on one side of the paper, while the other side can contain background information and any required disclosures.
When creating the consent form (and for all other messaging as well) we recommend you consider the following:
- If translating into additional languages, use simple language, avoid idiomatic expressions and cultural references, and remember that most other languages are longer than English and will require more space.
- Use broad terminology that can apply to to any vaccine formulation (intramuscular, intranasal, etc.) so your program can nimbly respond to a changing vaccine market and adapt to any production disruptions. For example, reference flu “vaccine” not “shot”.
- Assume a 4th grade reading level for all copy.
- Formatting matters! If it is unclear to those filling out the form where to place the information (below the line, above the line, or which box), you may find they put it in the wrong place or leave off information.
- Consider ordering questions or answers so that it’s easier to review and screen a form. For example, in the sample provided the choice of insurers are not in alphabetical order. Instead, the top line are all answers that correlate with a publicly/uninsured participant and the rest of the options correlate with a privately insured participant. If you are screening for eligibility for vaccine from different funding sources, ordering the answers this way makes it easier to review.
- Gather feedback on your draft form from a diverse audience including parents/guardians, school staff, healthcare providers, and community organizations. Note that throughout all of our materials we refer to both parents and guardians to be inclusive of all family types.
- Test out the form with a group of parents/guardians before finalizing.
- Print on a colored piece of paper that will stand out from other school handouts.
To consider when distributing the form:
- Provide envelopes for teachers to collect forms by class (example on the next page).
- Provide a receptacle for form collection in the front office (example on the next page).
- Distribute 3-4 weeks prior to vaccination—medical information may change if forms are distributed too far in advance.
You may consider having all families fill out a consent, marking “accept” or “decline”. Doing so can help you learn how many parents/guardians are actively declining participation and why. But weigh the pros and cons—doing so increases the risk that you may vaccinate a “decline” consent form student in error.
You will note that the provided consent form does not have a place to document the vaccine given. A label sticker can be used with the required information (date given, lot number, expiration date, manufacturer, administrator, etc.) and applied to the information side of the consent prior to vaccination. When the vaccinator administers the vaccine, or is unable to, they can document on the sticker the appropriate information. In our version we also include prompts to make sure the vaccinator confirms student identity (FN = first name, LN = last name, etc.). We also use pre-printed lot number stickers so the vaccinator did not need to write it in every time.
Vaccine Information Statement (VIS)
A VIS must be read by any vaccine recipient—or their parents/guardians—prior to vaccination. While we initially sent paper copies, we came to rely primarily on our website to share the VIS in all languages.
If you also opt for electronic distribution, either by emailing the VIS or posting it on a website for download, consider also providing hard copies for parents/guardians to access at the school as not all families may have ready access to the internet. For example, a folder of a hard copy of each language can be kept in the front office should a parent/guardian request a copy. You may also include an option to request a mailed copy; we notified parents of this option via our consent form.
The most updated version of the VIS, as well as translations, can be found on the Immunization Action Coalition (IAC) website: http://www.immunize.org/vis/
Refer to CDC’s webpage on VIS for more information: https://www.cdc.gov/vaccines/hcp/vis/about/facts-vis.html.
The CDC’s Advisory Committee on Immunization Practices (ACIP) meets in June and their resulting recommendations on influenza vaccination are posted in the months following. These recommendations may result in a VIS update thus we advise that all digital links to the VIS direct to the IAC website for the most up-to-date version of the VIS. Translated VIS may be delayed or never be translated at all.
Parent/Guardian Notification Form
This template can be used to inform parents/guardians whether or not their student was vaccinated and if not, the reason why. Additional information can be included with this form but it relies on the student taking it home and sharing it with their family. It is advised to use a heavier cardstock and a color—such as yellow—for printing.
Notification forms are easily lost and we explored other ways of notifying families, including placing a bracelet on students that received a vaccine stating “I got my flu vaccine today!” After surveying parents/guardians, we found that most of them never saw the bracelet and thus we discontinued this extra measure to inform families. We also explored stickers but felt we would encounter the same issue as the bracelets. Finally, we explored using a hand stamp for students vaccinated but found there was not an ink type that showed well on all skin colors.
Consent Form Data Entry
If there is a local or statewide immunization registry, we hope that you will enter all records from your program into the registry. In doing so, here are some important steps in the process:
- Meet with registry staff to determine the best plan for entry, for example individual record entry versus entering records into a spreadsheet for bulk uploading
- Determine which staff will be able to enter the data—consider using volunteers
- Build training and gaining access to the registry for data entry staff into your program timeline
- Determine the timeframe for which records will be entered into the registry and communicate this timeline with local healthcare providers
- Consider using the registry to gather additional information that will help you in program planning or evaluation as the registry permits