Grants8 | The most comprehensive grants search on the web

Grant Analysis

Purpose & Target

This grant provides investigators with access to biological samples from the Adolescent Brain Cognitive Development (ABCD) Study, the largest longitudinal study of brain development and child health in the U.S.
The primary objective is to maximize the scientific potential of these biospecimens for conducting research on child and adolescent health.
This is a SECTOR-SPECIFIC opportunity, targeting research institutions and scientists focused on adolescent health, neurodevelopment, and related fields.
Geographic scope is global, open to both U.S. and non-U.S. entities.
Key filtering criteria include the need for specific biospecimens for research and having secured independent funding to conduct the proposed research.
This is a recurring resource access program, active with multiple submission windows until May 2026.

Financial Structure

No funds are provided through this resource access opportunity (X01 activity code).
The grant explicitly states $0 for Total Federal Funds Requested, Total Federal and Non Federal Funds, and Estimated Program Income.
Applicants are solely responsible for all costs associated with conducting the research and for the shipment of biospecimens from the repository to the investigator.
Applicants must provide proof of sufficient external funding (e.g., Notice of Award from another grant) at the time of application to cover these research and shipping costs.
There are no matching fund or co-financing requirements from the X01 itself, but successful application is contingent on having external funding.
No specific financial reporting or audit requirements apply to the X01 award itself, as no funds are disbursed.

Eligibility Requirements

Eligible Organizations

All types of higher education institutions (public, state, private)
Non-profit organizations (with or without 501(c)(3) IRS status)
Local, State, and Federal Government entities, including U.S. Territories/Possessions and Indian/Native American Tribal Governments
Independent School Districts, Public Housing Authorities, Native American Tribal Organizations, Faith-based or Community-based Organizations, Regional Organizations
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Required Registrations

Applicant organizations must complete and maintain active registrations with:
- System for Award Management (SAM), renewed annually.
- NATO Commercial and Government Entity (NCAGE) Code (for foreign organizations).
- Unique Entity Identifier (UEI) (obtained via SAM.gov registration).
- eRA Commons (organization must have at least one Signing Official and one Program Director/Principal Investigator account).
- Grants.gov (requires active SAM registration).
Program Directors/Principal Investigators (PD/PIs) must have an eRA Commons account, affiliated with the applicant organization.

Project/Applicant Specifics

Applicants must have secured sufficient funding to conduct the proposed research and cover costs associated with sample distribution. Proof of funding is required.
Proposed research must be consistent with ABCD Study objectives or broaden the understanding of adolescent health.
Clinical Trials are Not Allowed.
Investigator(s) should demonstrate familiarity with the study that produced the samples being requested.
Applicant organizations may submit more than one application, provided each is scientifically distinct.

Application Process

Pre-Application Steps

Explore available biospecimens: Utilize the NBDC Portal Biospecimen Explorer to determine relevant samples.
Submit Biospecimen Availability Inquiry: Recommended at least 4 weeks prior to the application due date via the NBDC Portal. This inquiry determines sample availability and consistency with informed consents.
Secure Funding: Obtain sufficient funding from other sources to cover all research costs, including biospecimen shipment. Proof of this funding is mandatory at the time of application.

Application Deadlines

Multiple application due dates are available; the latest is 2026-05-05 17:00:00-04:00 (5:00 PM local time of applicant organization).
Letter of Intent (Biospecimen Availability Inquiry) due 30 days before the application due date.

Submission Process

Applications must be submitted electronically through NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system (S2S) solution.
Required Documentation/Materials:
- SF424(R&R) Cover: Enter '$0' for all funding fields.
- Other Attachments:
  - PDF file labeled 'Resource Availability and Impact Report' (provided by NBDC after inquiry).
  - PDF file labeled 'Funding Source' (proof of external funding, e.g., Notice of Award).
- Senior/Key Person Profile: Biosketches highlighting investigator's familiarity with the ABCD Study.
- PHS 398 Research Plan:
  - Research Strategy: Detailed sections on Significance, Approach, Biospecimens Information (justification for choice, numbers, volumes, timepoints), Methodology/Assays (details for each assay including volume, kit name, validation, QC plan), Power and Effect Size calculations, Statistical Analyses (detailed plan, team's expertise, addressing statistical issues, sex/race/ethnicity considerations), and discussion of potential harms to marginalized groups with mitigation strategies.
- Letters of Support: Resource Availability and Impact Report serves as a letter of support. If using biospecimens from other studies, provide commitment letters from collaborators.
- Data Management and Sharing Plan: Not applicable for this NOFO.

Review Process

Applications are evaluated by a federal review panel (NBDC Biospecimen Access Committee, BAC) for scientific and technical merit.
Application review typically takes approximately 2 months. Resource Access notifications are made within 3 months of the X01 review.
Applicants will receive a written critique accessible via the NBDC portal.

Post-Approval Requirements

Within three months of approval notification, applicants must:
- Confirm the biospecimen manifest provided by NBDC.
- Submit an Institutional Review Board (IRB) letter documenting approval or exemption of the proposed project.
- If applicable, provide letters of commitment from collaborators for other studies.
- Execute the NBDC Specimen and Data Transfer Agreement (SDTA).
- Complete the NBDC Responsible Data and Biospecimen Use Training.
- Agree to the NBDC Biospecimen Access Code of Conduct.

Post-Shipment Activities & Reporting

Annual Project Updates: Submit annually, starting one year after biospecimen shipment, covering progress on analyses, publications, funding changes, and data sharing.
Final Project Update: Due six months after biospecimen analyses are completed, including status of residual biospecimens, data sharing demonstration, and manuscript citations.
Data Sharing: All research results must be de-identified and deposited in the ABCD Study data archive, linking analyses to relevant ABCD Study collection/participants. Recipients must agree to the ABCD Study data archives' Data Use Certification.

Evaluation Criteria

Applications are evaluated for scientific and technical merit by a federal review panel. The following criteria contribute to the Overall Impact Score: Significance

How well does the project address an important problem or barrier to progress in the field?
How will scientific knowledge, technical capability, or public health policy be improved?
How adequately does the project's impact on remaining biospecimen amounts match its scientific significance? Studies significantly depleting the collection must be appropriately significant.

Investigator(s)

Are the PD/PI(s), collaborators, and other researchers well-suited with appropriate experience and training?
For collaborative projects, is expertise complementary and leadership/structure appropriate?
How adequately has the investigator demonstrated familiarity with the study that produced the samples?

Innovation

Does the application propose novel theoretical concepts, approaches, methodologies, instrumentation, or interventions?
Is there a refinement, improvement, or new application of existing concepts/approaches?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate for the specific aims?
Have plans been made to address weaknesses in prior research rigor?
Are strategies for robust and unbiased approaches in place?
How adequately can the study aims be accomplished using ABCD Study samples and data?
How sufficient is the applicant's secured funding to conduct the proposed study?
How fully does the proposed study take advantage of the ABCD study design, and how will requested samples maximize its benefits?
How sufficient are preliminary data for demonstrating accuracy and robustness of proposed assays?
How adequate is the laboratory quality control plan?
Are power calculations and requested sample sizes adequate to detect significant effects?
How adequate is the statistical analysis plan, including addressing measurement error, multiple comparison testing, bias, interactions, and data adjustments?
How sufficiently justified is the use of race- and ethnicity-related constructs, and how appropriately are they contextualized?
How adequate is the discussion of potential harms to marginalized individuals/groups/communities, and how appropriate are mitigation strategies?
Is the team's expertise and experience sufficient for the proposed analyses?
For human subjects research, are plans for protection from risks and inclusion/exclusion of diverse populations justified?

Environment

Will the scientific environment contribute to success?
Are institutional support, equipment, and physical resources adequate?
Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Considerations (not separately scored)

Human Subjects Protections: Evaluation of justification for involvement, protection against risks, benefits, and importance of knowledge gained.
Inclusion: Evaluation of plans for inclusion/exclusion based on sex, race, ethnicity, and age.
Vertebrate Animals: Assessment of procedures, justifications, and minimization of discomfort if applicable.
Biohazards: Assessment of potential hazards and proposed protections for personnel/environment.
Foreign Organizations: Assessment of special opportunities offered by international collaborations (unique talent, resources, populations).

Compliance & Special Requirements

Regulatory and Ethical Compliance

Adherence to NIH Grants Policy Statement and relevant Federal Regulations (42 CFR Part 52, 45 CFR Part 75, 2 CFR Part 200).
Human Subjects Protection: Compliance with 45 CFR Part 46 for research involving human subjects, including justification for involvement, protection against risks, and ethical considerations.
Inclusion Policy: Plans for the inclusion or exclusion of individuals based on sex, race, ethnicity, and age must be justified.
Environmental Compliance: Assessment of potential biohazards and proposed protections.
Labor Standards: Not explicitly mentioned for this X01.

Data Management and Intellectual Property

Data Sharing: Mandatory de-identification of all research results and deposition into the ABCD Study data archive. No transfer of data to any other entity or individual is allowed.
Data Use Agreements: Required to sign the NBDC Specimen and Data Use Agreement and ABCD Study data archives' Data Use Certification.
Genomic Data Sharing: If genetic analyses are proposed, applicants must address all elements of the Data Management and Sharing Plan, including those specific to genomic data sharing.
Intellectual Property: Not explicitly detailed beyond data sharing policies for research results.

Special Considerations

Resource Access Only: This is solely a resource access award; it does not provide any funding. Applicants must demonstrate existing sufficient funding from other sources to conduct the proposed research and cover all associated costs.
Clinical Trial Exclusion: This opportunity is explicitly not for clinical trials.
Sample Depletion: The proposed project's impact on the amount of sample remaining in the NBDC Biorepositories will be considered relative to the significance of the proposed project.
Marginalized Groups: Applications must discuss potential harms to marginalized individuals, groups, or communities whose biospecimens are requested and propose mitigation strategies.
International Applicants: Foreign institutions are eligible but are responsible for costs associated with shipping samples outside the U.S. and obtaining necessary import documentation for biohazardous material.
Acknowledgements: Recipients must use the specified Research Resource ID (SCR_015769) and acknowledgement language when referencing ABCD Study materials and data in publications and presentations.

Grant Details