Informed Consent Guide · The Undoctored
Parent Informed Consent Guide · The Undoctored

Before You Sign:
Your Right to Ask Questions

For parents in the NICU, delivery room, or any hospital setting where vaccines are offered

This guide supports informed consent — it does not recommend refusing any vaccine or medical treatment. Asking questions before consenting is your right and is always appropriate. Final medical decisions should be made with your care team.
Your legal standing
Informed consent is a legal right, not a courtesy. Before consenting to any medical procedure for your child, you have the right to receive complete information, ask questions, and take time to decide. Asking questions is not the same as refusing — it is the standard of care. You have the right to request additional time and information before giving final consent to non-emergency procedures. No procedure should proceed while your consent is still under review.
How to open the conversation
Say this first — it sets a collaborative tone
"I want to make sure I fully understand what's being given before I sign. I have a few questions — can you help me work through them?"
This signals: I'm cooperative, I want to proceed responsibly, I'm not here to create conflict. Most staff will respond positively to this framing.
Questions to ask — copy word for word if helpful
About the product itself
1"Can I see the full FDA package insert for this vaccine — not the summary sheet, the full insert?" The Vaccine Information Statement (VIS) is a one-page CDC summary. The full insert is the manufacturer's legal document filed with the FDA. It is a public document available at fda.gov and you may request it before proceeding.
2"Is this a pediatric formulation or an adult formulation?" Some vaccines come in two strengths. For Hepatitis B, the adult dose contains twice the aluminum of the pediatric dose. Verify before administration.
3"What ingredients does this formulation contain — specifically the adjuvant?" Adjuvants are immune-stimulating compounds, typically aluminum salts. Knowing the type and quantity is reasonable due diligence.
About your right to consent
7"I'd like time to review the package insert before I decide. Can we schedule this for tomorrow?" This is a reasonable request for non-urgent vaccines. It is not refusal — it is informed consent in practice. Note: if your Hep B status was positive or untested, the birth dose has a time-sensitive clinical window — discuss timing with your OB before deferring.
8"If we defer this vaccine, what specifically changes in my baby's care plan or discharge timeline?" Helps you understand the clinical rationale for the timing.
9"If I have questions after reading the insert, who is the right person to talk to — the attending, a resident, or the charge nurse?" Establishes the correct escalation path before you need it.
If you feel pressured
→"I'm not refusing — I'm asking for time to review. That's my right."
→"I'd like to speak with the attending before I sign. Can you let them know?"
→"Is there a patient advocate I can speak with about this?"
→"I'd like it noted in the record that I have questions pending review."
Rights you already have
✓Request the full package insert — it is a public document
✓Take time before signing consent for any non-emergency procedure
✓Ask for the attending physician to discuss the plan
✓Have your questions added to the medical record
✓Request a patient advocate — every hospital has one
For informational and educational purposes only. This guide does not constitute medical or legal advice and does not recommend refusing any vaccine or treatment. Medical decisions should be made with your care team. Package inserts: fda.gov/vaccines-blood-biologics/vaccines
theundoctored.comAdditional resources & documentation
Before You Sign: Your Right to Ask Questions
Parent Informed Consent Guide · continued
Additional questions — specific to NICU / premature infants
For premature or medically fragile infants
4"My baby currently weighs [X grams / lbs]. The FDA has a guideline of 5 mcg/kg/day for aluminum in premature infant IV nutrition. Can you tell me how the aluminum in this dose compares to that threshold for my baby's current weight?" This question demonstrates specific knowledge of FDA benchmarks and signals that you have reviewed the clinical literature. It often prompts a more substantive conversation with the medical team.
5"The package insert states that vaccination should be deferred during moderate or severe acute illness. Given my baby's current clinical picture, can the attending explain the reasoning for proceeding today rather than deferring?" This language comes directly from the manufacturer's own insert — you are asking the team to document their decision relative to the manufacturer's own guidance.
6"Has my baby's primary attending reviewed and approved the timing of this vaccine given their current status?" You are asking for physician-level accountability, which is appropriate. Vaccines in the NICU are sometimes initiated by nursing or resident staff without attending review of timing in fragile infants.
What the package insert actually says
Section 13.1 — Nonclinical Toxicology of every FDA vaccine package insert is required to address three questions: Has this product been evaluated for carcinogenic potential? For mutagenic potential? For potential to impair fertility?

The answers, stated verbatim in the manufacturers' own legally submitted documents:

"GARDASIL 9 has not been evaluated for its carcinogenic or mutagenic potential." — Gardasil 9 Package Insert, Sec. 13.1
"INFANRIX has not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility." — Infanrix Package Insert, Sec. 13.1
"Engerix-B has not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility." — Engerix-B Package Insert, Sec. 13.1

These are the manufacturer's own words in a legal document submitted to the FDA. Available in full at fda.gov/vaccines-blood-biologics/vaccines.
How to find package inserts
Direct source
fda.gov/vaccines-blood-biologics/vaccines → select the vaccine → "Package Insert"
You can also search: "[vaccine name] package insert FDA" — the full PDF is a public document. Print or screenshot Section 11 (ingredients) and Section 13 (nonclinical toxicology) specifically.
Key sections to read in any package insert
Sections that answer your questions
11Description / Ingredients — full ingredient and adjuvant list including aluminum in mcg
13Nonclinical Toxicology — carcinogenic, mutagenic, and fertility testing status
5Warnings and Precautions — contraindications, special populations
6Adverse Reactions — trial observations and post-marketing surveillance
VIS vs. full package insert
→The VIS is the one-page CDC summary handed to you in clinics. Required by law — it is not the package insert.
→The package insert is the manufacturer's full legal submission — 20–40 pages, containing data the VIS does not include.
→You have the right to request the full insert before consenting. Look it up at fda.gov — it is a public document.
For informational and educational purposes only. This guide does not constitute medical or legal advice and does not recommend refusing any vaccine or treatment. Medical decisions should be made with your care team based on your child's individual clinical situation.
theundoctored.comAdditional resources & documentation