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Grant Analysis

Purpose & Target

This grant aims to support investigator-initiated research that uncovers the specific biological and molecular mechanisms by which bariatric surgery impacts cancer risk, moving beyond just weight loss outcomes. - Primarily targets research institutions and organizations with the capacity to conduct in-depth scientific studies, including universities, non-profits, and for-profit research entities. An R01 grant implies established research infrastructure. - SECTOR-SPECIFIC - Geographic scope is limited to U.S.-based applicant organizations. Foreign components or collaborators are allowed, but the lead applicant must be a U.S. entity. - Key filtering criteria include a focus on mechanistic studies, involvement of bariatric surgery and cancer risk, and exclusion of purely epidemiological or in vitro studies. Clinical trials must include a bariatric surgeon as a key investigator. - This is a recurring funding opportunity (reissue of PAR-21-331) from the National Cancer Institute (NCI) as part of NIH's broader effort to understand cancer prevention and treatment.

Financial Structure

Maximum direct costs are $500,000 per year.
This grant does not require matching funds or cost-sharing.
Financial reporting includes annual Research Performance Progress Reports (RPPR), a final RPPR, an invention statement, and expenditure data (Federal Financial Report) for closeout.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Indirect cost policies are not explicitly detailed in this NOFO but are generally covered by NIH Grants Policy Statement.

Eligibility Requirements

Eligible Applicant Organizations

Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education
Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Small Businesses
For-Profit Organizations (Other than Small Businesses)
State Governments
County Governments
City or Township Governments
Special District Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribal Governments (Other than Federally Recognized)
Eligible Agencies of the Federal Government
U.S. Territory or Possession
Independent School Districts
Public Housing Authorities/Indian Housing Authorities
Native American Tribal Organizations (other than Federally recognized tribal governments)
Faith-based or Community-based Organizations
Regional Organizations
Foreign organizations are not eligible to apply as the lead applicant. Non-domestic components of U.S. organizations are not eligible as the lead applicant. However, foreign components (e.g., specific sites or collaborators) as part of a U.S. lead application are allowed.

Required Registrations

Active registration in the System for Award Management (SAM), requiring annual renewal. This includes obtaining a Unique Entity Identifier (UEI).
Active registration in eRA Commons, with at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
Active registration in Grants.gov.
All registrations must be completed prior to application submission.

Eligible Individuals (PD/PI)

Any individual with the skills, knowledge, and resources to conduct the proposed research.
For clinical trials, a bariatric surgeon must be a key investigator on the team.

Exclusion Criteria

Applications proposing solely epidemiological studies as the primary aim.
Applications focused entirely on in vitro investigations.
Studies that do not evaluate tissue and/or bodily fluid samples collected from participants who have undergone bariatric surgery (with some having developed cancer after surgery).

Application Process

Application Deadlines

There are multiple application due dates until January 8, 2028. The latest application due date for new applications is October 5, 2027. For renewal/resubmission/revision applications, the latest due date is November 5, 2027.
All applications are due by 5:00 PM local time of the applicant organization.
Applicants are encouraged to submit early to allow time for corrections. If the due date falls on a weekend or federal holiday, it's extended to the next business day.
The grant has an Expiration Date of January 8, 2028.

Submission Methods

Applications must be submitted electronically through:
- NIH ASSIST system
- An institutional system-to-system (S2S) solution
- Grants.gov Workspace

Required Documentation and Materials

Follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide and program-specific instructions in this NOFO.
Standard forms include: SF424(R&R) Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile.
Budget forms: R&R or Modular Budget, R&R Subaward Budget.
PHS 398 Cover Page Supplement.
PHS 398 Research Plan, which must include a Data Management and Sharing Plan for all applications generating scientific data.
Appendix: Only limited materials allowed (e.g., blank questionnaires/surveys; no publications).
PHS Human Subjects and Clinical Trials Information form: Required if human subjects are involved, including a study record for clinical trials.

Pre-Application Requirements/Recommendations

Letter of Intent (optional): Recommended 30 days prior to the application due date, including proposed activity title, PD/PI info, key personnel, participating institutions, and funding opportunity number.
For clinical trials, strongly encouraged to contact NCI staff (Edward R. Sauter) no later than 12 weeks prior to the application due date to discuss the proposed trial.

Post-Award Requirements & Compliance

Annual Research Performance Progress Reports (RPPR) and financial statements are required.
A final RPPR, invention statement, and expenditure data are required for closeout.
ClinicalTrials.gov registration and results submission are required for applicable clinical trials.
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval is required for human subjects research.
Data and Safety Monitoring (DSM) is required for human biomedical and behavioral intervention studies (clinical trials).
Compliance with Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements for projects involving investigational therapeutics/devices.

Evaluation Criteria

Overall Impact

Reviewers will assess the likelihood of the project having a sustained, powerful influence on the research field. This is the primary consideration.

Scored Review Criteria

Importance of the Research (Significance and Innovation): Evaluates the importance of the research question and the potential for innovative approaches.
Rigor and Feasibility (Approach): Assesses the soundness of the research design, methodology, and the feasibility of the proposed work.
Expertise and Resources (Investigator(s) and Environment): Reviews the qualifications of the research team and the adequacy of the institutional environment and resources to conduct the project.

Additional Review Criteria (not scored, but considered)

Protections for Human Subjects: Evaluation of the adequacy of plans for the protection of human participants.
Vertebrate Animals: Assessment of the care and use of vertebrate animals.
Biohazards: Consideration of potential biohazards and proposed mitigation.
Resubmissions/Renewals/Revisions: Appropriateness of revisions or expansions from previous applications.

Additional Review Considerations (not scored, but influence overall impact)

Authentication of Key Biological and/or Chemical Resources: Plans for ensuring validity of resources.
Budget and Period of Support: Justification and reasonableness of the requested budget and project duration in relation to the proposed research.
Program Priorities: Relevance of the proposed project to NCI's program priorities.

Compliance & Special Requirements

Regulatory Compliance

Compliance with Public Health Service Act (42 USC 241 and 284), Federal Regulations 42 CFR Part 52, and 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards).
Adherence to all applicable nondiscrimination laws (attested to during SAM.gov registration).
Mandatory disclosures of federal criminal law violations (fraud, bribery, gratuity) potentially affecting the federal award.

Data Protection and Privacy

A Data Management and Sharing Plan is mandatory for all applications generating scientific data. This plan must be implemented upon approval.
ClinicalTrials.gov registration and results reporting are required for applicable clinical trials.

Ethical Standards

Compliance with protections for human subjects and vertebrate animals.
Ethical considerations are reviewed as part of the overall application.

Risk Management and Security

Proposed plans for identifying and ensuring the validity of key biological and/or chemical resources will be evaluated.
Projects are subject to NIH Grants Policy Statement regarding risk.

Unique Aspects and Strategic Opportunities

This NOFO specifically encourages studies on the mechanisms that explain the effect of bariatric surgery on cancer risk, differentiating from simple weight loss outcomes.
There's a preference for studies focusing on bariatric surgery procedures currently in common use (sleeve gastrectomy, RYGB).
Encouragement for collaborators from fields outside of cancer research to foster interdisciplinary approaches.
Human biospecimens and/or data from existing cohorts (e.g., LABS, Teen-LABS, NCI Cohort Consortium Members) can be utilized to enhance proposed studies.

Grant Details