The National Institutes of Health is making $50 million available to study autism, but many researchers in the field are leery of the new initiative, which they say is rushed and skirts typical protocols.

The effort known as the Autism Data Science Initiative aims to use data from a variety of sources to help understand what causes autism and what’s driving increasing prevalence of the developmental disability. In addition, projects will work to understand how existing treatments and interventions are used in order to guide the design of future studies.

Federal officials say they expect to provide up to $5 million each for 10 to 25 projects through the initiative that will last two to three years.

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“ADSI is intended to bring together diverse data resources, researchers and community members to further our understanding of autism and develop new knowledge that can be used to improve health outcomes for people on the autism spectrum,” Doug Sheeley, deputy director of the NIH Office of Strategic Coordination, said in a webinar about the effort.

The NIH said that projects through the new initiative could rely on datasets from a wide variety of sources ranging from Medicaid and the National Survey of Children’s Health to genetic data from the Autism Speaks MSSNG Database and many more. Applications must include a community engagement plan describing how people with autism, their families, caregivers, clinicians, service providers, advocacy organizations or other stakeholders will be involved. What’s more, the announcement said that data use will comply with privacy and confidentiality requirements under federal and state laws as well as policies from the NIH and the U.S. Department of Health and Human Services.

Despite the large amount of money available, many researchers in the field are skeptical of the funding announcement that was released in late May, which they say is out of the ordinary in several ways.

Notably, the NIH is using what’s known as an “Other Transaction” funding mechanism for the Autism Data Science Initiative. This approach gives NIH staff significantly more control over projects than is typical, according to Helen Tager-Flusberg, director of the Center for Autism Research Excellence at Boston University and founder of the Coalition of Autism Scientists, a group of more than 250 researchers in the field.

“The OT permits far greater involvement of NIH staff: for example, they can require independent funded investigators to collaborate; take the datasets generated by the funded investigators and conduct their own analysis; choose to stop the funded project before the end,” she said. “It opens up the possibility of NIH staff using an investigator’s data for purposes that were not intended by that investigator — either for themselves or providing the data to other groups.”

In addition, Tager-Flusberg noted that NIH staff will be involved in the peer review process, something that she said “is unheard of for standard grant applications.” And, the initiative calls for just one level of review as opposed to the typical two-step process that involves scientists and community members.

The Coalition of Autism Scientists wants to see the NIH commit to an independent external advisory board of autism scientists and community members for the Autism Data Science Initiative.

Researchers have until June 27 to submit proposals for the initiative, a much quicker turnaround than usual.

“Another concerning issue is the rapidity with which the process from announcement to the application submission deadline is taking place, allowing just one month for applicants to pull together a large-scale, collaborative scientific proposal,” said David G. Amaral, a professor at the UC Davis M.I.N.D. Institute.

The funding announcement comes after the NIH said it partnered with the Centers for Medicare & Medicaid Services to access data on Medicare and Medicaid enrollees with autism to establish a “Real World Data Platform,” to allow research across claims, electronic medical records and consumer wearables.

However, NIH officials said that the Autism Data Science Initiative is separate from the data platform. While both are data focused, the agency said that the Autism Data Science Initiative is a research initiative, while the Real World Data Platform will establish a new infrastructure to study chronic disease and autism will serve as its initial case study.

Autism researchers are facing financial pressure, with data showing that federal funding for autism research was down 26% during the first four months of this year.

Officials with the NIH and HHS did not respond to questions about the Autism Data Science Initiative.

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