In recent weeks, the National Institutes of Health (NIH) announced new directors at three of its institutes and centers (ICs). Additionally, the National Institute of Allergy and Infectious Diseases (NIAID) released its updated strategic plan, reflecting a new approach to infectious disease research. The institute is also seeking public comment on a proposed reorganization. And for researchers, the HEALthy Brain and Child Development (MBCD) Study 2.1 Data Release is now available for approved users.
New Institute and Center Leadership
NIH recently announced new directors at three ICs: the National Institute of Child Health and Human Development (NICHD), the National Library of Medicine (NLM), and the National Center for Complementary and Integrative Health (NCCIH). Following previous appointments in July and early August, eight ICs remain without permanent directors, down from a high of 16 in February.
Most relevant to FABBS members, John Gaitanis, MD, took over as Director of NICHD on August 23. Dr. Gaitanis is a pediatric neurologist specializing in conditions such as epilepsy and autism, and, prior to joining NIH, served as Chief of Child Neurology at Tufts Medical Center and Director of Child Neurology at Brown Medical School. Following the announcement, concerns arose within the scientific community about his qualifications. As recently reported in Science, Dr. Gaitanis appears to have no prior experience with NIH — no funding, peer review, or Advisory Council service — begging questions about his knowledge of the agency and, therefore, his ability to lead it. Additionally, his previous support for unproven alternative treatments (e.g., for autism) and possible vaccine skepticism have raised flags in the stakeholder community.
At NLM, Peter Embí, MD, stepped in the Director’s role on September 10. Dr. Embí is credited as a founder of the field of clinical research informatics — which focuses on optimizing the design, conduct, analysis, and dissemination of clinical research. He is recognized as originating algorithmovigilance — the systematic evaluation and monitoring of AI in health care. Prior to joining NIH, he served as a professor of biomedical informatics and internal medicine at Vanderbilt University Medical Center. Dr. Embí is also a member of the National Academy of Medicine.
Wendy Weber, PhD, MPH, a naturopathic physician, is now Director of NCCIH. Unlike Drs. Gaitanis and Embí, Dr. Weber has a long history at NIH, having joined NCCIH as a program director in 2009. She worked her way up the center’s leadership ladder, most recently serving as Chief of Clinical Research in Complementary and Integrative Health within the Division of Extramural Research. She also briefly served as the Acting Director of this division. Prior to joining NIH, her research focused on complementary treatments for pediatric conditions such as ADHD.
NIAID Proposed Reorganization and New Strategic Plan
In early September, NIAID released a reorganization plan that would dismantle its Division of Clinical Research (DCR), established in 2006 to coordinate research involving human participants. NIAID proposes to shift DCR’s projects, programs, partnerships, and functions to three other units with the institute: the Office of the Director, the Division of Intramural Research (DIR), and the Division of Microbiology and Infectious Diseases (DMID). NIAID also plans to establish new offices and laboratories, including an Office of Biostatistics Research within the NIAID Office of the Director, with a Biostatistics Research Branch and a Clinical Trials Research and Statistics Branch. Supposedly, these changes will better align NIAID’s work with Presidential priorities, reflect an updated mission, and ensure accountability, transparency, and rigorous scientific review of research.
Notably, all of these changes are being proposed when the institute is without a permanent director – and has been since April 25. NIAID has invited public comments on the proposed changes. Stakeholders can submit feedback using this form any time before September 18.
NIAID also released its updated Strategic Plan for 2026-2030 last week. According to the institute, the new plan takes a more integrated, person-centered approach to studying infectious and immune-mediated diseases, focusing on a deeper understanding of human immunology. Significantly, the plan no longer includes any mention of biodefense. At the recent NIH Council of Councils meeting, NIH Dr. Jay Bhattacharya revealed that, because NIAID is a civilian agency, it will no longer handle biodefense (see FABBS reporting).
HBCD 2.1 Data Release Now Available
In good news for researchers, the HEALthy Brain and Child Development (MBCD) Study 2.1 Data Release is now available. The HBCD Study is the largest long-term study of early brain and child development in the U.S. and is supported through a partnership of a dozen NIH ICs. So far, over 5,000 families have been enrolled at 27 research sites across the country. Researchers can access the HBCD data through the NIH Brain Development Cohorts (NBDC) Data Hub, along with data from the Adolescent Brain Cognitive Development (ABCD) Study. To secure access, researchers must complete the required training, certifications, and security compliance steps.
This newest release includes high-quality prenatal and longitudinal data from more than 3,500 participants, such as MRI and EEG data, demographic data, mental and physical health measures, and social and environmental determinants. New data elements in this update include inflammation biomarkers and the Early Regulation in Context Assessment (ERICA) (see the 2.1 release notes).
