This article, shared clinical decision making, was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Law, San Francisco, who is a frequent contributor to this and many other websites, providing in-depth and intellectually stimulating articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively about the social and legal aspects of vaccination in law journals. Reiss is also a member of the Parent Advisory Board of Voices for Vaccines. This parent-led organization supports and advocates for on-time vaccination and the reduction of vaccine-preventable diseases. She is also a member of the Vaccines Working Group on Ethics and Policy.

I have received numerous questions about what shared clinical decision making (SCDM) means, so here is a brief explanation. The bottom line is that shared clinical decision making is a term of art that contrasts with routine vaccination — it means that not everyone in a certain population (age, gender, or other groups) should receive a vaccine, only individuals for whom the doctor recommends it. It does not mean “this is the only way to get doctors to discuss vaccines with patients” — informed consent is required for any vaccine. 

Why did shared clinical decision-making become a thing?

In its meeting in September 2025, the Advisory Committee on Immunization Practices (ACIP) made this recommendation for COVID-19 vaccines: 

VOTE: The pediatric and adult immunization schedules for administration of FDA-approved COVID-19 vaccines should be updated as follows:

• Adults 65 and older: Vaccination based on individual-based decision-making*

• Individuals 6 months to 64 years: Vaccination based on individual-based decision-making—with an emphasis that the risk-benefit of vaccination is most favorable for individuals who are at an increased risk for severe COVID-19 disease and lowest for individuals who are not at an increased risk, according to the CDC list of COVID-19 risk factors.

*Also known as shared clinical decision making.

On October 6, 2025, the Acting Director of CDC, Deputy Secretary Jim O’Neill, signed the recommendation (CDC Director’s signature is needed for the recommendation to become final; Vaccines for Children recommendations are different). Director O’Neill added the following statement: 

“Informed consent is back,” said Deputy Secretary O’Neill. “CDC’s 2022 blanket recommendation for perpetual COVID-19 boosters deterred health care providers from talking about the risks and benefits of vaccination for the individual patient or parent. That changes today.”

The recommendation and these comments caused substantial confusion, in part because they do not correctly reflect what shared clinical decision making is, and in part because of the confusing language of the committee – “individual decision making” is not a legal term, and does not mean shared clinical decision making. Language matters in law. 

This post is to help people understand what shared clinical decision-making is. 

What is shared clinical decision making?

Shared clinical decision-making is a legal term of art that contrasts with routine vaccination. CDC explains it thus:

Unlike routine, catch-up, and risk-based recommendations, shared clinical decision-making vaccinations are not recommended for everyone in a particular age group or everyone in an identifiable risk group. Rather, shared clinical decision-making recommendations are individually based and informed by a decision process between the health care provider and the patient or parent/guardian.

The key distinction between routine, catch-up, and risk-based recommendations and shared clinical decision-making recommendations is the default decision to vaccinate. For routine, catch-up, and risk-based recommendations, the default decision should be to vaccinate the patient based on age group or other indication, unless contraindicated. For shared clinical decision-making recommendations, there is no default—the decision about whether or not to vaccinate may be informed by the best available evidence of who may benefit from vaccination; the individual’s characteristics, values, and preferences; the health care provider’s clinical discretion; and the characteristics of the vaccine being considered. There is not a prescribed set of considerations or decision points in the decision-making process.

What does that mean? ACIP usually makes routine recommendations for vaccines. For example, every child should get their DTaP vaccine as early as six weeks (in practice, it’s usually at two months), and then again at other defined times. Doctors following this recommendation would suggest the vaccine for every child of that age, unless the child has a contraindication.

Informed consent

Does that mean, as Director O’Neill’s comments implied, that there’s no informed consent for those vaccines? Of course not. Informed consent is a general requirement between doctors and patients. Doctors do not grab the baby from the parents’ arms and vaccinate the baby by force, nor do they force the parents to consent. In reality, they have a discussion.

Further, doctors are required, under federal law, to provide parents with a Vaccine Information Statement that, among other things, sets out the vaccine’s risks and benefits. This document is a pretty good “informed consent” document, though in my opinion, ideally, it would be given before the visit with a chance to ask questions, and that’s not really the way it’s done in practice.

But let’s be clear: doctors and patients do talk to each other when vaccines are routinely given. And it’s an individual decision between the doctor and patient in each case (see below on mass clinics and pharmacies). The contrast ACIP and Director O’Neill tried to draw here shows, at best, a misunderstanding of how informed consent works in vaccination.

When should shared clinical decision making be used, and what does it actually mean? 

Shared clinical decision making is recommended when ACIP does not think there’s justification for a routine recommendation, but wants to make the vaccine available for special cases. It’s a rare designation. As the CDC lists, ACIP only has five recommendations of that variety so far, and it’s usually when ACIP does not think there’s a benefit to universal vaccination. 

The message when you designate the vaccine under shared clinical decision making is that most people likely won’t need it. It reduces uptake. Among other things, it’s unclear what it means, because providers may not initiate or may conclude that they need to carefully investigate records to decide who to recommend to, and it may take longer to explain to people why they need a vaccine not universally recommended, and because insurance coverage may be spotty. 

There is substantial confusion about what it means in practice, and I want to highlight some of that:

• Who initiates? It’s unclear. Of course, if a patient comes in and says, “I heard of this vaccine, can I get it?” – like I’m planning to do for my sons for the meningococcal B vaccine, when they reach the age – the doctor will entertain the conversation. But it’s not clear if the doctor needs to mention these vaccines at all unless the patients do, and doctors are likely to vary dramatically in that.
• What kind of process is needed? There is no indication that this process requires anything more than the usual informed consent process required for any vaccine. There’s certainly not a clear “this is what you need to talk about.” I bet that in pharmacies and doctor offices, any discussions are going to happen only if people are hesitant or do not want COVID-19 vaccines when the doctor recommends them – and that would have happened anyway. I doubt people who are going in knowing they want the vaccine will have any lengthy discussion.
• What happens in mass clinics and pharmacies? Pharmacies addressing COVID-19 vaccines seem to be leaning towards only discussing whether people want it. There are some questions these places have to ask to make sure people know what they’re getting, and if there are contraindications, so some discussion always happens.
  
  But people who go to mass clinics or go to pharmacies to get a vaccine are, essentially, looking for the vaccine, and are less likely to be looking for lengthy discussion – and I doubt those are going to happen. If shared clinical decision making were interpreted to require a prescription, which it currently is not, it could make it harder to get vaccines. But right now, I would be surprised if it results in any change in the dialogue for COVID-19 vaccines. 
• Is this covered by insurance? The HHS statement said that:

Like routine recommendations, individual-based-decision-making allows for immunization coverage through all payment mechanisms including entitlement programs such as the Medicare, Medicaid, Children’s Health Insurance Program, and the Vaccines for Children Program, as well as insurance plans regulated by the Affordable Care Act.

But it’s not clear at all that that’s true.  The Preventive Services provision of the Affordable Care Act requires coverage of vaccines recommended by ACIP, and the regulations interpret this to require coverage of immunization for routine use.

The regulations say that “[a] recommendation is considered to be for ‘routine use’ if it appears on the Immunization Schedules of the CDC.” Shared clinical decision-making is included on the schedule, so my interpretation is that yes, it is required to cover these, in line with HHS.

But, as Richard Hughes and I have said elsewhere, “because this terminology is inconsistent with ordinary practice, it has created ambiguity as to whether payors are required to cover vaccines recommended based on shared clinical decision-making…”

But there have been issues with coverage and payment. 

So, the bottom line is — shared clinical decision making does not mean “let’s have more informed consent.” It means “let’s not give the vaccines to everyone, only to those who need them,” and creates real confusion around how the process should be implemented.

It leads to less vaccine uptake and potentially insurance coverage issues, and most importantly, it’s a signal from ACIP that not everyone should get the vaccine, only special cases, which can lead to lower vaccine uptake. I suspect that’s part of the revised ACIP’s intent, but Director O’Neill should know better than to mischaracterize what this means.