Informed Consent and Vaccines

By Dorit Reiss

The process of informed consent is more regulated for vaccines than for most medical treatments or drugs. Still, anti-vaccine activists often use “informed consent” as part of their general attack on vaccines. Parents, they say, are not given appropriate information about vaccines and their risks, so they cannot make an informed decision about them. That claim is incorrect.

When I teach my students about informed consent and vaccines, I use the Vaccine Information Sheet (VIS) - the basis of informed consent in this area – as a model, because it is a reasonably good form. To understand why, you need to first understand what informed consent means, and how it works in the context of vaccines.

The Basics of Informed Consent

Informed consent has two parts: the patient has to consent, or agree, to a treatment, and the consent has to be made after the patient has been given sufficient relevant information. Our system values patient autonomy very, very highly. With a few narrow exceptions (court order, emergency, lack of capacity to consent), a doctor may not provide treatment to a non-consenting patient. Even if the lack of treatment will kill that patient. An adult in sound mind has the right to choose death over treatment. A doctor providing treatment without consent may be liable for a battery (see Schloendorff v. Society of New York Hospital, 211 N.Y. 125, 105 N.E. 92 (1914).) However well-intentioned the doctor, she may not give treatment without consent.

For a child, the consent of the child’s legal guardian  - usually the parent – substitutes for the child’s consent. There are some exceptions to that – doctors may treat children in an emergency when no parent is around; a state may mandate treatment over a parent’s opposition, through legislation or court order, in some circumstances; and most states allow adolescents to consent to certain treatment without parental permission.

Informed consent cases are different. In those cases, the patient actually consented to the procedure. The claim, however, is that that consent was flawed, because the patient did not have complete information. It is a claim that the doctor was negligent in providing the information necessary for the patient to fully understand the situation and make an informed decision (Natanson v. Kline, 350 P.2d 1093 (1960)). To evaluate informed consent, courts use one of two approaches. Some courts compare the information provided to the patient to the information a doctor in good standing would provide—what is customary in the profession to give. This is referred to as the professional standard, or the physician standard. It requires expert testimony on the standard in the profession.

Other courts ask the jury to compare the information given to the patient to what a reasonable patient in the plaintiff’s shoes would consider important. This is referred to as the patient standard or the material risk standard.

If a patient underwent a treatment without informed consent, a doctor may be liable for harms arising from that treatment – even if the treatment was performed properly, even if there was no medical malpractice.

Informed Consent and Vaccines

What would a person need to know to give informed consent to a vaccine under this rubric (or what would a parent need to know to give informed consent to vaccinate a child, which is the more common situation)? A parent would need to know “the nature of the treatment” – that the child is getting a vaccine, whether it’s injected or oral; the “risks and benefits” of the treatment – the benefits of the vaccine, in other words, the risks from the disease we vaccinate against; the risks of the vaccine – potential side effects; and alternatives, which do not really exist for vaccines.

In 1986 Congress passed the National Childhood Vaccine Injury Act. The act did a number of things, but the important part for our purposes is that it required the Secretary of the Department of Health and Human Services to

“develop and disseminate vaccine information materials for distribution by health care providers to the legal representatives of any child or to any other individual receiving a vaccine set forth in the Vaccine Injury Table. Such materials shall be published in the Federal Register and may be revised.” (§300aa-26).

The materials developed require – for their initial preparation and any revision – a 60-day notice and comment process with the public, and consultation with “the Advisory Commission on Childhood Vaccines, appropriate health care providers and parent organizations, the Centers for Disease Control and Prevention, and the Food and Drug Administration.”(id – see http://www.law.cornell.edu/uscode/text/42/300aa-26).

Today, any health care provider administering a vaccine is legally required to provide these materials to the individual – or a guardian, in the case of a child – before giving the vaccine.

These materials – referred to as the Vaccine Information Sheets – can also be found on the CDC’s website. 

Examining one selected at random – the DTaP Vaccine Information Sheet - the VIS opens with “Why get Vaccinated” - including a description of the diseases, who should or should not get the vaccine, and the potential risks from the vaccine. It also provides instructions of what to do if, after the vaccine is administered, a reaction develops,which include calling your doctor or going to an emergency room, reporting the reaction to the Vaccine Adverse Event Reporting System, and information about the compensation mechanism.

In short, a parent reading through the Vaccine Information Sheet should get a good sense of why the vaccine is given, what are its benefits and risks, and additional information, such as what to do if there’s a problem. This seems to cover the requirements of informed consent. The hope is that the recipient of the VIS will read it before the vaccination. Of course, all doctors can do is provide the information. It is the responsibility of the patient or her legal guardian to read it.

Anti-vaccine Claims and Responses

Anti vaccine activists like to claim that no informed consent is given before vaccinating. As explained above, these claims are incorrect. These individuals base their claims on three arguments, none of which is valid.

First, they suggest parents should be given the vaccine insert as part of the consent process. Second, they claim parents are not told that vaccines can cause a range of  side effects (side effects that have not been scientifically documented and, in the case of some, have been disproven) such as SIDS or autism. Finally, they criticize the fact that parents are often not informed of the ingredients before being the vaccine is administered.

I will take these objections one at a time.

Not giving the insert:

The insert – of a vaccine or a drug – is not a good document to base informed consent on. The insert is a legal document, heavily regulated by the FDA. It has substantial useful information, but can also mislead the patient (see: http://www.skepticalraptor.com/skepticalraptorblog.php/vaccine-package-inserts-debunking-myths/ for a detailed discussion of inserts). In relation to informed consent, at least two problems make inserts inappropriate: they do not explain the benefits of the procedure; and they must legally list any problem that occurred after the product was put on the market, whether or not causally related to the vaccine. The combination of not mentioning the benefits and mentioning unrelated bad outcomes can make the vaccine look much worse than the reality – substantial benefits and low risk – and misinform parents.

Not mentioning “side effects” like autism and SIDS

However much anti-vaccine activists would like to believe otherwise, extensive scientific studies have examined whether vaccines cause autism or SIDS– and no connection was found. That is why these risks are not mentioned on the Vaccine Information Sheet. Mentioning risks that are not supported by evidence is not promoting informed consent: it’s undermining it.

Not Providing Parents with a List of Ingredients

A list of ingredients is not part of informed consent requirements for any drug. If a patient has a known allergy to an ingredient, or a potential allergy, they should, of course, be notified of the presence of that ingredient. But otherwise, a list of ingredients alone – in the abstract – does not promote the patient’s understanding of the risks or benefits of a procedure, and does not advance the patient’s ability to decide if the procedure’s benefits outweigh the risks. It is therefore not a proper part of the informed consent discussion.

The informed consent process for vaccines is carefully regulated and thought through. A serious effort is made to provide patients with the information they need in a short, accessible format. As long as the healthcare provider performs the legal duty of providing the Vaccine Information Sheet before vaccinating, the patient – or parent – has before them the information necessary to make an informed decision.

Certain parents, because of language problems or other problems, may need more help, and should receive it; but that is true of any informed consent process.  It does not mean the process itself is in any way flawed.    

Author's Note: I'm grateful to Nathan Boonstra, Ashley Shelby, and Alice Warning Wasney for their corrections to previous drafts.

Dorit Reiss is a professor of law at the University of California. She has published writings on administrative law, and recently wrote "Compensating the Victims of Failure to Vaccine: What are the Options" Dorit is a member of Voices for Vaccines' Parent Advisory Board.

Everlee's Story

Editor's Note: A couple of months ago, we heard about a five-week-old infant in an ICU here in the Twin Cities who had been diagnosed with pertussis , and was battling for her life.  A few weeks ago, the mother of that strong-willed little girl, who fought the pertussis tooth-and-nail and won, got in touch with the Minnesota Department of Health asking for ways she could share her story of a life forever changed by a vaccine-preventable disease. Emily Stevenson's story is below.

UPDATE: CBS affiliate WCCO led the news tonight (2/9/2012) with Emily and Everlee's story. Click the link to watch it.

Everlee, five weeks old, in the ICU

I am the mother of a beautiful four month old baby girl.  When our daughter was 5 weeks old she began having a mild cough.  Within a few days her coughing spells became much more frequent and intense, she developed a fever, and started having apnea episodes where she would stop breathing for several moments.  It became clear that we were dealing with something very serious.  

We brought her to the doctor where our fears were confirmed: she was diagnosed with pertussis (whooping cough).  We were surprised at how this could happen, as everyone in our family had received the Tdap (diphtheria-pertussis-tetanus) vaccine (Editor's note: Tdap is the pertussis booster for teens and adults; Dtap is the pertussis vaccine course for infants and children).  There was a confirmed case of pertussis in our older daughter's classroom, and although a fluke, we learned that it was possible for the bacteria that causes pertussis to have traveled home on her clothes.  Our baby daughter was at the time too young to receive the DPT vaccine and was vulnerable to being exposed to pertussis.  

She was hospitalized right away, and as her coughing spells became more intense and worrisome she was moved into the intensive care unit.  There was very little that the doctors could do for her as she weathered through the peak phase of the illness.  Pertussis causes intense coughing spells along with other respiratory complications, and is particularly dangerous for infants because of their immature respiratory system.  Our baby had trouble clearing away the thick mucus in her airway and was continuously deprived of oxygen.  The illness also placed considerable stress on her small heart due to the pressure that had built in her chest. Unfortunately, these consequences are typical for an infant with pertussis.  

The weeks that we spent in the hospital were very difficult.  Our baby fought hard against a respiratory illness that her body was not ready to handle.  Each day we watched her struggle for breath, unable to eat or sleep, and have to linger in pain.  We are thankful for her strong will and for the good medical care that she received.  After three weeks in the ICU her symptoms began to wane indicating that she was past the peak phase of the illness.  We were able to bring her home to recover.  Her cough will last for several more weeks, but we are grateful for every day that she shows improvement. 

Everlee caught pertussis from an unvaccinated child

The reality is that pertussis can be largely prevented by the Dtap vaccine.  There are several children in our older daughter's grade level whose parents have chosen to opt out of having them receive the Dtap and other vaccines.  After this experience, we view their choice as part of a frightening trend.  In reality, what our baby went through could have been prevented.  

Parents who choose not to have their children vaccinated fail to realize that they are actually putting infants, and others who are vulnerable, at a high risk.  We have learned that because of this trend the incidence rate of pertussis in Minnesota has grown considerably over the past few years.  We are hopeful that for the safety of individual families and the community that more parents will heed the advice of medical professionals and make the choice to have their children vaccinated.

View from the Exam Room: Baby's First Immunizations

Today my younger sister took her two-month-old daughter to get her first vaccinations. She asked me to be present. After we talked to the doctor about the baby's bowel movements, her tendency to spit up, her impressive head and neck strength, we got the vaccination question. At that point, my sister got tongue-tied, and she turned to me.

"Obviously you don't turn away unvaccinated children," I jumped in, "but I think what my sister is concerned about is exposure to infected unvaccinated children in your waiting room. We can't control the general population--who knows who is vaccinated and who isn't when we go to the mall. But several infants have been infected in waiting rooms and emergency rooms by unvaccinated children waiting for treatment." The doctor nodded and seemed grateful to hear from a couple of so-called "pro-vax" moms for once.

"You're right," she said. "We don't turn away unvaccinated children. We try to convince the parents to vaccinate, of course, and give them the facts." She continued. "We had a case of measles here on Friday." It was like the air was sucked out of the room. The doctor was pregnant herself. I mentioned that I thought that must have been a bit scary for her. "Luckily, I was on the other side of the clinic at the time," she said. "But we have very clear protocols for handling that."
"Do other parents have the right to be notified?" my sister asked.
"Yes, we notify anyone who might have been in the waiting room that day, and if we suspect the child has measles, we put him in a specific room in the clinic."

I looked at my sister. This didn't see like enough. And I agreed. "It's really refreshing to hear from this point of view," the doctor added. "Parents who are concerned about unvaccinated children." She told us that since the Twin Cities measles outbreak, some parents who had, to this point, left their children unvaccinated had relented and brought their kids in for vaccines. I found this a hugely positive step.

Then it was time for the vaccines. The physician's assistant had set down a piece of paper and said: "Here are the vaccines for this visit. She then said: "You'll be getting shots for these eight diseases," and went down the list. I cringed. As soon as she left, I turned to my sister. "This will actually consist of two injections." Her eyes had grown wide, because it sounded like this baby was going to get eight shots. Going down the laundry list of diseases a combo vaccine prevents has become rote, but health providers really need to give careful consideration to the way they present these vaccinations. "These PAs need to be trained in how to talk about vaccines in ways that don't mislead or scare parents," I said to my sister. "Geez!"

In the end, my baby niece got three injections (dTaP--Diptheria, Tetanus and Pertussis--protecting her against three of the most devastating diseases known to man; Pneumonococcal, which prevents a disease that can lead to meningitis; and her Hep B vaccine, since she hadn't gotten it at birth).

When my sister laid her baby on the exam table, she said, "Oh, look at her looking at me, all trusting and loving." I said: "She's trusting you to do what's best for her because you love her. And you are."