Environmental influences on Child Health Outcomes (ECHO) Cohort Data and Biospecimen Access (X01 Clinical Trial Not Allowed)

The Environmental influences on Child Health Outcomes (ECHO) Cohort Data and Biospecimen Access program, issued by the National Institutes of Health (NIH), invites eligible institutions and investigators to apply for access to limited identifiable data or biospecimens from the ECHO Cohort. This program announcement (PAR-25-437) represents a non-funded X01 Resource Access Award and is required for those seeking to conduct ECHO Cohort Ancillary Studies—defined as studies using non-ECHO funding to analyze non-publicly available ECHO data or biospecimens. The ECHO Program was launched by NIH in 2016 to improve child health across generations and is administered through a consortium of research cores and centers. The cohort currently includes data on approximately 130,000 maternal and child participants and over 123,000 biospecimens, covering every U.S. state, Washington D.C., and Puerto Rico. This opportunity enables broad participation from the scientific community, including researchers both within and external to the ECHO Cohort Consortium. Whether requesting access to biospecimens or just data, all applicants must receive an X01 award under this announcement to proceed. The X01 designation ensures that all ancillary studies adhere to NIH and ECHO-specific procedures and oversight requirements. Importantly, this award does not provide funding but grants access to the specified resources, with applicants required to secure separate, non-ECHO funding to support their proposed studies. Applicants are expected to propose research that advances high-priority areas in maternal and child health using ECHO data and, if applicable, biospecimens. These may include studies on developmental exposures, resilience and susceptibility to adverse outcomes, sensitive periods in development, and the impact of environmental innovations or policy changes on health. Proposals should demonstrate methodological rigor, explain the scientific significance, and provide detailed plans for biospecimen handling, laboratory processes, data security, and privacy safeguards. Studies should generate data that can be broadly reused and must include plans to return assay results to the ECHO Data Analysis Center. To be considered, applicants must include a Letter of Support from the ECHO Cohort Steering Committee and demonstrate evidence of non-ECHO funding adequate to cover the study’s costs, including biospecimen handling, data platform usage, and personnel. Instructions for obtaining the necessary Letter of Support and preparing budgets for ECHO Cores and Centers are detailed on the ECHO website. Applications without a Steering Committee Letter of Support will not be reviewed. The program opens for submissions on June 18, 2025. Multiple review cycles are offered annually, with deadlines in July, November, and March through 2028. The earliest start date for the initial submission cycle is September 2025. Applications are submitted electronically through Grants.gov using NIH ASSIST or other system-to-system solutions, with adherence to the NIH Application Guide required. The research strategy is limited to six pages. Projects may not exceed a three-year period and must not include clinical trials. For scientific inquiries, applicants should contact Dr. Melissa Zajdel at melissa.zajdel@nih.gov. The X01 mechanism does not result in a formal Notice of Award but provides awardees with instructions to access ECHO data and biospecimens upon approval. This announcement falls under the authority of the Public Health Service Act and adheres to all applicable federal regulations and NIH policy standards.

Applicants are encouraged to apply early to allow time for corrections, must include all required elements (especially evidence of funding and ECHO Steering Committee Letter), and should carefully follow all application and submission instructions.