Purpose

The purpose of this Program Announcement with Special Receipt, Referral, and/or Review Considerations (PAR) is to solicit applications to access limited identifiable data or biospecimens from the ECHO Cohort to study high-priority areas of maternal and child health. Obtaining an award from this opportunity is necessary to participate in the ECHO Cohort ancillary studies process. The ECHO Program defines an ECHO Cohort Ancillary Study as a study that derives funding from a non-ECHO source and uses the ECHO Cohort’s non-publicly available data or biospecimens.

ECHO Cohort Ancillary Studies are open to the broad scientific community and require investigators who are not a part of the ECHO Cohort Consortium to apply for and receive an X01 award under this announcement. Investigators who are currently part of the ECHO Cohort Consortium who are requesting access to biospecimens as part of an ancillary study must also apply for and receive an X01 award under this announcement. While no funds are associated with awards from this announcement, these X01s allow the NIH ECHO Program Office to oversee awardees’ adherence to NIH and ECHO-specific policies and procedures during performance of ECHO Cohort Ancillary Studies.

This opportunity allows individuals across the scientific community to propose projects that leverage non-ECHO funding to conduct ancillary studies involving

• Analysis of limited identifiable data on the ECHO Cohort Data Platform
• Access to biospecimens from the ECHO Cohort Biorepository to generate new assay data for subsequent analysis and to return these data to the ECHO Cohort Data Platform 

To learn more details about the ECHO Cohort ancillary studies process, go to https://echochildren.org/-echo-ancillary-studies/.

Research Scope

Applications to this announcement should consist of well-conceived projects that leverage limited identifiable data on the ECHO Cohort Data Platform, with or without assays of biospecimens, to study high-priority areas of maternal and child health.

Applicants may propose any scientific question appropriate to the use of ECHO Cohort data. Specific areas of interest include, but are not limited to

• Detecting modifiable early developmental exposures that, if addressed by programs, policies, and practices, could enhance child health outcomes across the life course
• Exploring pathways to child health outcomes that incorporate state-of-the-art analytic biochemical or statistical methods
• Examining resilience or susceptibility factors that buffer or amplify the effects of adverse early exposures on child health outcomes
• Identifying periods of development most sensitive to specific beneficial or detrimental exposures to inform new strategies to promote child health.
• Measuring the effects of natural experiments or new health innovations or paradigms on child health outcomes.

Scientific questions may benefit from assays of ECHO Cohort biospecimens to characterize exposures, pathways, or outcomes. Ideal projects would include assays that generate results that are usable in multiple future analyses.

Specific Application Requirements and Expectations

Letter of Support for ECHO Ancillary Studies

To be responsive, applications to this announcement must include as an attachment a Letter of Support from the ECHO Cohort Steering Committee. NIH will not review applications without a Letter of Support from the ECHO Cohort Steering Committee. Find instructions on how to request a Steering Committee Letter of Support at https://echochildren.org/echo-ancillary-studies/.

For applications submissions to the first due date listed in this announcement, applicants must request a Letter of Support in early June 2025. Find specific dates for requesting Letters of Support from the ECHO Cohort Steering Committee at https://echochildren.org/echo-ancillary-studies/.

Evidence of Funding

ECHO Cohort Ancillary Studies require support from non-ECHO funding sources. This announcement does not provide funds for the research project. Applicants are responsible for providing their own funding to cover all costs associated with conducting the research, including accessing data and biospecimens.

Applications to this announcement must include evidence of adequate funding in-hand or having applied for funding sufficient for the study. Applicants must provide evidence that funding will cover:

• Investigators and staff time
• Establishment of material transfer agreements and data transfer agreements with the ECHO Cohort Consortium, including with the ECHO Laboratory Core and Data Analysis Center
• Costs for the ECHO Cohort Cores and Centers—ECHO Data Analysis Center, Coordinating Center, Laboratory Core, and/or Measurement Core—for the duration of the study period, including but not limited to
  • Training and certification by the ECHO Data Analysis Center so applicants can access and conduct data analysis on the ECHO Cohort Data Platform analysis workbench
  • Set up of a limited identifiable dataset by the ECHO Data Analysis Center
  • If the applicant proposes biospecimen assays, retrieving, aliquoting, packing, and shipping of biospecimens from the ECHO Laboratory Core to the assay laboratory, and return of biospecimens to the Laboratory Core, if required by the ECHO Cohort Biospecimens Policy
  • Consultation with the ECHO Measurement Core about data elements collected in the ECHO Cohort, including the meaning, complexity, and best use of specific measurements
  • Project management and support from the ECHO Coordinating Center for navigating the ECHO Cohort analysis proposal and publications processes

Find more information at https://echochildren.org/echo-ancillary-studies/ about how to prepare appropriate budgets for ECHO Cores and Centers to support the proposed ancillary study.

Biospecimen and Assay Data Quality and Security Measures

If proposals include the use of ECHO Cohort biospecimens, applications must include detailed information about the analytical laboratory, planned assays, and plans for implementing biospecimen and assay data quality and security measures. See Section IV below for more details.

Plans should include protection of ECHO Cohort research participants’ privacy and against risk of re-identification. Learn more about NIH expectations for protecting participant privacy at https://sharing.nih.gov/data-management-and-sharing-policy/protecting-participant-privacy-when-sharing-scientific-data.

Expectation of Returning Biospecimen Assay Data to ECHO

Project proposals should include plans to return biospecimen assay data to the ECHO Data Analysis Center. Applicants should acknowledge in their proposals that the ECHO Cohort Consortium does not release biospecimens to assay laboratories until official material transfer agreements and data transfer agreements are in place.