Monday, January 20, 2014

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

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.

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: 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.

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