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In the U.S., children are vaccinated primarily in their pediatrician’s or family doctor’s office (Groom, 2007). Because the idea of vaccinating children at school may be unfamiliar to some parents/guardians, there may be reluctance to consent to influenza vaccination at school. Parents/guardians may seek the advice of others, including their child’s health care provider (Woodruff, 1996). For this reason, the success of SLV programs also will be enhanced by enlisting the support of local health care providers, especially pediatricians, family practitioners, obstetrician/gynecologists (since they often serve as primary care providers for adolescent girls), and community health clinics. Partnerships with organizations such as the American Association of Pediatricians and the American Academy of Family Physicians may also add to the success of the SLV program and assist in gaining support from local physicians. Attached is a template letter to providers [32 KB, 1 page] . Having mechanisms in place to disseminate vaccination information to healthcare providers will also help gain backing from local health care providers.
Hopefully, most providers will be supportive of the SLV clinics, but some may be concerned about vaccinations occurring outside of their offices, especially with regard to keeping their patient records up-to-date and having adequate information in case a patient seeks care for a possible vaccine-related adverse event. The need to conduct SLV programs to ensure children are vaccinated in a timely manner can be explained given the likelihood that providers will be busy treating ill patients. Keeping providers informed about planned SLV clinics also will help them estimate how much influenza vaccine they will need to order for their own patients.
The following are suggestions on the development of materials that should be delivered — via the child, mail, and/or email — to parents/guardians to inform them of the planned SLV clinic and solicit their permission to vaccinate their child. Each of the following materials should be translated and available in various languages, as locally appropriate.
Among materials provided to parents/guardians should be a letter announcing that influenza SLV clinics will be offered at their child’s school. Typically, this letter is sent out as a cover letter to accompany other materials, including the consent form, information about the vaccine, and when the SLV clinics are scheduled to occur. Such a letter also could be sent well in advance of the planned SLV date, perhaps even before vaccine is available in the area.
The requirement to seek parental consent prior to vaccination, and the exact format and elements that must be included on a standard consent form, generally are not governed by federal law or regulation. Instead, requirements for informed consent are legislated or regulated by each state or jurisdiction, including the circumstances under which minors can consent to their own medical treatment. If planning on obtaining advanced consent, planners should discuss this approach with state and local legal advisors before deciding to implement it. Planners also should consider whether state/local law would require separate consents for administration of each dose of a two dose vaccine series.
Attached are three templates that SLV program planners may use as starting points for developing consent forms in accordance with applicable state and local laws and requirements. These template consent forms can be modified to conform to state and local requirements. As some influenza SLV programs do not offer second doses of influenza vaccine, these consent forms were developed for programs administering only one influenza vaccine to students. If a second dose of influenza vaccine will be offered, additional information about influenza vaccination histories may need to be collected.
While consent to be vaccinated is generally not regulated by federal law, federal law (as well as state law) may regulate the vaccinator’s use or disclosure of individually identifiable health information regarding the child.
The first template consent form is designed for the injectable formulation of the vaccine, the second template consent form is designed for the intranasal formulation of the vaccine, and the third form is designed for both the injectable and the intranasal formulations. The choice of which consent form(s) to distribute to parents/guardians will depend on which vaccine formulation (live-attenuated intranasal vaccine [LAIV], inactivated injectable vaccine, or both) will be offered at the SLV clinic.
See the Template Consent Forms:
Below are notes about each section on the template consent forms:
Information about child to receive vaccine: This section includes suggestions for collecting personal and demographic information.
Screening for vaccine eligibility: This section includes standard vaccination eligibility screening questions for either the injectable or both injectable and intranasal formulations of the vaccine.
Consent: This section includes a statement and signature line for parents/guardians to consent to or decline vaccination on behalf of their child. Also, planners may consider including an option for parents/guardians to select the type of vaccine (e.g., intranasal, injectable, or no preference) they prefer be given to their child with a statement that the preference will be honored depending on vaccine availability and the child’s eligibility. Note that state laws vary regarding whether one parental signature will suffice for both doses.
Vaccination record: This section includes suggestions for collecting information regarding the vaccine and its administration.
SLV program planners may also want to include a section for consent or authorization for disclosures of certain vaccination, medical, personal, and/or demographic information. Student information contained in the vaccine consent form may be protected by state or federal privacy laws or regulations. Requesting such authorization may be recommended or necessary, depending on local needs and/or laws such as the Family Educational Rights and Privacy Act (FERPA) or the Health Insurance Portability and Accountability Act (HIPAA).
The following are examples of authorizations that could be sought by SLV program planners including a statement with a request for a parental signature on the consent form:
The entity conducting the vaccination program is responsible for only using and disclosing a child’s health information consistent with applicable laws. For example, the entity should know whether it is subject to the HIPAA Privacy Rule, which only applies to certain health care providers, to health plans and to health care clearinghouses, to FERPA, which only applies to educational agency or institutions receiving Department of Education funding, and/or to other Federal or state laws.
Entities subject to the HIPAA Privacy Rule may use or disclose a minor’s health information with the signed authorization of the parent or a guardian with authority to make health care decisions for the child using a form that meets HIPAA requirements or without such authorization for treatment purposes and certain public health and other purposes. (Note: FERPA and HIPAA issues are discussed below under “Legal Issues”).
State and local planners may consider distributing consent forms to parents in advance of influenza vaccine availability. The benefits of such a procedure, if determined to be legally viable and feasible in the jurisdiction that will be offering influenza SLV clinics, are that vaccine may be expeditiously given to consented children as soon as it is received by the vaccinator, and planners may be better able to plan for adequate staff, vaccine, and supplies.
To provide parents/guardians with information on which to base their consent decision, parents/guardians could be given Influenza Vaccine Information Statements (VIS), which describes the best current understanding of the expected risks and benefits of the influenza vaccines (see VIS for the inactivated, injectable formulation of the vaccine and VIS for the live, attenuated intranasal formulation of the vaccine). Along with a cover letter (see Template Letters Seeking Advanced Consent for Vaccination [26 KB, 1 page] and Template to Alert Parents to Upcoming Planned Clinics). To document their consent decision, parents would also need be given an appropriate consent form to complete and return to the school (see Template Consent Form for Use With Intramuscular, Injectable Formulation of Vaccine, Template Consent Form for Use with Live, Attenuated, Intranasal Formulation of Vaccine, and Template Consent Form for Use With Both the Intramuscular, Injectable Formulation and Live Attenuated, Intranasal Formulation of Vaccine).
If parental consent for vaccination is obtained substantially in advance of the time that the vaccine is to be administered to the child, a mechanism must be provided for the parent/guardian to withdraw consent prior to the time of vaccination, if desired. A mechanism should also be provided for a parent/guardian who initially declines to give consent for his/her child to be vaccinated to subsequently change that election and give consent for the child to be vaccinated. Additionally, if it is anticipated that LAIV will be offered, plans should be in place to confirm that the child has not received another live vaccine (e.g., varicella or measles, mumps, rubella [MMR] vaccines) within four weeks of the SLV clinic.
If planners decide to pursue consent substantially in advance of the time that the vaccine is to be administered to the child , as described above, an informational packet also could be sent slightly in advance of the clinic (e.g., two or three weeks in advance). This procedure could serve to announce or remind parents of the clinic date, provide an official VIS form for those who have not received one, and remind parents/guardians of mechanisms to change their consent status.
Planners should discuss this approach with state and local legal advisors before deciding to implement it. Planners also should consider whether state/local law would require separate consents for administration of each of a two dose vaccine series.
Important information about the use of the template consent form is provided above. Please also refer to the section below on “Legal issues” for important information on liability, licensing, FERPA, and HIPAA.
Vaccine Information Statements (VISs) are information sheets produced by the CDC that explain to vaccine recipients, their parents, or their legal representatives both the benefits and risks of a vaccine. They also include information about indications and eligibility for each vaccine. An appropriate VIS (depending on which formulation of influenza vaccine is being offered–inactivated, injectable formulation or live, attenuated intranasal formulation) should be included among materials provided to parents/guardians before and after vaccine administration.