Autism Registry Raises Concern Over Ethics, Privacy And Intended Use

Robert F. Kennedy Jr. made controversial statements about autism in a press conference on April 16. Among the most shocking, after claiming that “Autism destroys families,” was that “These are kids who will never pay taxes. They’ll never hold a job.” Kennedy, who has long claimed that vaccines cause autism, then announced a new study that will “identify precisely what the environmental toxins are that are causing” autism. He also promised to have answers by September.

The National Institutes of Health then announced an autism registry last week, with director Dr. Jay Bhattacharya saying that the database would be comprehensive and include government and commercial records. For example, it would compile medication records, lab and genomics data, insurance claims and data from a smartwatches or fitness trackers. He indicated NIH was also negotiating with the Centers for Medicare & Medicaid Services to access its data. At the same time, he promised “state-of-the-art protections” for privacy.

In response to the initial outrage over Kennedy’s statements about autism and the announcement of the registry, the administration has backtracked, now claiming that no registry will be made and that NIH will only be linking existing datasets.

The outrage and concern continue, as many do not trust the administration not to backtrack again. There are many other serious problems with the Kennedy/Bhattacharya proposal.

Studying The Cause Of Autism

One pediatrician, Alison Escalante M.D., who specializes in neurodivergent kids, describes the spectrum of presentations of kids as she debunks much of what Kennedy said. For one, most scientists believe autism to be a developmental disorder, likely with a genetic basis. Yet the administration has chosen David Geier, a prominent anti-vaxxer and controversial figure who was disciplined for practicing medicine without a license, to look again at links between vaccines and autism, although these have been debunked by numerous scientists in the past.

Dr. Paul Offitt, a leading vaccine researcher, told MedPage Today, “I think one can expect that with David Geier at the helm and Kennedy as head of HHS, we may soon see a study that shows that vaccines cause autism, even though they don’t.”

Rhetoric Surrounding Disabilities And Eugenics

The language that Kennedy used about kids with autism was triggering to some people. As Dr. David Gorski, managing editor of Science-Based Medicine, said, “What he leads with is telling: ‘…these are kids who will never pay taxes, they’ll never hold a job…’ (Emphasis mine.) Let me say right here, this is some real, top grade, ‘useless eaters’ rhetoric.”

Saying “those with ‘severe autism’ ‘destroy families,’” Gorski continued, “is very reminiscent of the sorts of rhetoric used to justify the Aktion T4, the ‘euthanasia’ program instituted by the Nazis around the start of World War II to eliminate those with serious conditions that necessitated lifelong care in institutions.”

CMS administrator Dr. Mehmet Oz fueled these concerns by having previously said, while campaigning for Senate in 2022m that the uninsured “don’t have the right to health.”

Had the timing not been coincidental with outrage about the autism registry, the text from the Equal Employment Opportunity Commission to Barnard College employees might not have stirred such a strong response. But the EEOC asked, as part of a survey, for staff to self-identify if they’re Jewish or Israeli. Catherine Rampall, a journalist and MSNBC host, commented on Bluesky, “Ah yes, the government asking Jews to register as Jewish, in the name of protecting the Jews. No way that could go wrong.”

Other Ethical Concerns About An Autism Registry

Anne Borden, co-founder of Autistics for Autistics, raised related concerns about this registry, noting that there are already other autism registries that parents have consented to. A primary concern of hers is that work would proceed to identify a gene or marker for autism that would be developed into a prenatal test and be used to abort fetuses with autism.

If people are worried they will be listed in a registry, they might go underground — “that kind of misinformation can stop people from getting the kind of help that they really need, such as the diagnosis that can unlock funding for speech pathology,” Borden said.

She added that we need to stop seeing autistic people as burdensome and “we have to build a society that values autistic people, including those that Kennedy says don’t do their own taxes.”

Borden also wrote a book, The Children Do Not Consent, in which she decries the lack of ethics in how people with autism are studied in trials with proxy consent from their parents.

Borden cautioned, too, that in some places, autistic people were lower in triage for services like ICUs during the COVID-19 pandemic.

Research Ethics

The first thing any proposed autism registry would need under basic research ethical standards is informed consent. (I know; I wrote the textbook Conducting Clinical Research, which covers these topics.)

Health and Human Services leadership seemingly believes that HIPAA regulations do not apply and informed consent is not required because the data are deidentified. In Rolling Stone, Raymond Romanczyk of Binghamton University cautions that “AI systems and machine learning can glean a lot of information about a person with very little context.”

One of the problems with this registry is that it doesn’t appear to require the assent of the child if they are capable of that.

An additional problem is that the administration dismantled the Office for Human Research Protections, so there is likely less research ethics oversight.

“The process for establishing a scientifically valid and ethically appropriate research repository is complex,” Mark Rothstein, a lawyer and ethics professor, noted via email. “If they want to start a defensible research registry for autism or anything else it will take a great deal of thought, care, and consultation.”

Rothstein cautioned that the goals and procedures for such a registry should be clear in advance. Are there hypotheses? What information and specimens will be collected?

In addition to expanding on the concerns about confidentiality and deidentification of data, Rothstein raised this vital concern: “Because of the controversy surrounding the registry, what are the intended uses of the study, and will they advance the interests of individuals with autism?”

There is a cautionary tale in NIH’s “All of Us” research program. Despite additional planning, it also generated considerable controversy. Its informed consent notes that there are “risks to privacy” in an understated fashion. The study was criticized for suggesting that racial disparities in health are more from genetics than environmental factors and for fueling racial stereotypes.

While the NIH’s autism registry may be paused for now, we likely will see it again in some form. Far more care and planning are crucial as well as a robust informed consent process.

(I reached out to HHS for comment; will add to story if they respond).