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Grant Analysis

Purpose & Target

The 'NCI Research Specialist (Clinician Scientist) Award' (R50) aims to encourage stable research career opportunities for exceptional clinician scientists. These individuals are vital for sustaining the NCI-funded clinical trials enterprise by providing leadership in developing and implementing national clinical trials, and offering national service to NCI clinical trials networks. - Target Recipient Type: Clinician scientists with a clinical degree or relevant doctoral degree, actively practicing in oncology. - Target Recipient Size: Individual clinician scientists within academic medical centers or community centers that hold an NCORP award. - SECTOR-SPECIFIC: This grant is highly sector-specific, focusing on healthcare, particularly oncology and cancer research. - Geographic Scope: United States. - Key Filtering Criteria: Must be a clinician scientist, actively practicing oncology, involved in NCI-funded cancer clinical trial-related activities, and not holding significant other NIH research project funding (R01, P01). - Grant Frequency and Program Context: This is a reissued funding opportunity (reissue of PAR-21-306) with annual application due dates, indicating a recurring program to provide sustained support for critical roles in cancer clinical trials.

Financial Structure

This award provides salary support for the Research Specialist.
The salary support must be commensurate with the level of effort devoted to the institution's NCI-funded clinical trials activities.
Minimum effort funded by this award is 2.4 person-months (out of 12).
Maximum effort funded by this award is 4.8 person-months (out of 12).
The maximum total NCI-funded effort allowed for the Research Specialist across all NCI grants, including this R50, is 6 person-months.
Eligible costs include travel costs to attend research meetings/conferences, not to exceed $2,500 per year.
Eligible costs also include $2,000 per year for travel costs for the Principal Investigator to attend an annual meeting for Research Specialist (Clinician Scientist) Award recipients.
The total award project period may not exceed 5 years.
No cost sharing is required for this funding opportunity.
Ineligible costs: Research expenses are explicitly not covered by this award and must be covered from other sources awarded to the institution.
Financial reporting requirements include submission of the Research Performance Progress Report (RPPR) annually and financial statements. A final RPPR, invention statement, and expenditure data are required for closeout.

Eligibility Requirements

Organization Requirements

Must be located in the United States. Non-domestic entities or components of U.S. organizations are not eligible.
Eligible organizations include: Higher Education Institutions (Public/State Controlled, Private), Nonprofits (with/without 501(c)(3) IRS Status), For-Profit Organizations (Small Businesses, Other), Local Governments (County, City/Township, Special District, Indian/Native American Tribal Governments), Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations, Faith-based or Community-based Organizations, and Regional Organizations.
Applicant organizations must complete and maintain required registrations prior to submission: System for Award Management (SAM), Unique Entity Identifier (UEI), eRA Commons, and Grants.gov. Registration can take 6 weeks or more.
Must have a strong, well-established cancer clinical trials program related to the Research Specialist's area of expertise, with a high-quality research environment and productive collaboration opportunities.
Institutions are limited to submitting four applications per receipt date, including new, resubmission, and renewal applications. NCI-designated cancer center consortia are considered one institution.

Individual (Clinician Scientist) Requirements

Must possess a clinical degree (M.D., D.O., D.D.S., D.M.D., O.D., D.C., PharmD., N.D., D.V.M.) OR a Ph.D. or other doctoral degree that involves direct patient or healthy subject contact in clinical disciplines (e.g., clinical psychology, nursing, clinical genetics).
Must possess active licensure and be actively practicing in an oncology clinical setting.
Cannot hold current R01, P01, or other significant NIH funding as a Principal Investigator at the time of application. Support from P50 Career Development awards, R03, R21, P30 funding, or national network funding is allowed, provided total NCI support does not exceed 6 person-months.
Must have a record of involvement in NCI-funded cancer clinical trial-related activities and be engaged in the conduct of NCI-funded cancer clinical trials research.
Must be located at an academic medical center or a community center that holds an NCORP award (primary site).
Must have been at the current institution for at least the previous two years at the time of application.
Must have a full-time position at the institution.
Must be more than six years from initial faculty appointment at the time of application submission (including appointments held at other institutions).
Must commit 2.4 to 4.8 person-months of effort to NCI-funded clinical activities described in the Research Plan of the R50 application.
The maximum funded effort allowed from all NCI grants, including this R50, is 6 person-months.
Must have demonstrated professional accomplishments and cancer clinical research experience relevant to the NCI mission.

Application Process

Key Dates

Open Date (Earliest Submission Date): October 04, 2024
Application Due Dates: November 04, 2024 and November 04, 2025.
All applications are due by 5:00 PM local time of the applicant organization.
Expiration Date for the funding opportunity: November 05, 2025.
Earliest Start Date: July 2025 (for applications submitted by November 2024) or July 2026 (for applications submitted by November 2025).

Application Submission Process

Applications must be submitted electronically through NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system solution.
Applicant organizations and Program Directors/Principal Investigators (PD/PIs) must complete and maintain required registrations (SAM, UEI, eRA Commons, Grants.gov) prior to submission. Registration can take 6 weeks or more.
Applicants are strongly encouraged to submit early to allow time for correcting any errors.
Applications are subject to page limitations as described in the NIH 'How to Apply - Application Guide' and 'Table of Page Limits'.

Required Documentation and Materials

Standard application forms: SF424(R&R) Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile, R&R Budget, R&R Subaward Budget.
PHS 398 Cover Page Supplement and PHS 398 Research Plan.
Crucially, the Research Plan should NOT include Specific Aims.
The Research Strategy section must be organized into three subsections:
- Sub-heading A: Describe the scope of the clinical trials program(s) engaging the Research Specialist's activity/effort within NCI-sponsored clinical trials networks at the institution.
- Sub-heading B: Detail the particular activities, qualifications, experience, productivity, and accomplishments of the Research Specialist (PD/PI) in NCI-sponsored clinical trials, including their history of contributing to NCI networks and institutional clinical studies infrastructures.
- Sub-heading C: Outline plans to develop new research capabilities and/or approaches to improve the institution's clinical trials program, including plans to enhance recruitment of underrepresented minority groups and women to clinical trials.
A table summarizing the clinical trials in which the applicant has played a significant role is required, including funding source, National Clinical Trial ID, applicant's role, dates, status, phase, and accrual data.
Letters of Support are required and applications missing them will not be reviewed:
- One letter from the institution attesting to its strong cancer clinical trials program, high-quality research environment, and commitment to continued institutional support for the Research Specialist's effort.
- At least three letters of recommendation from PDs/PIs who can attest to the Research Specialist's qualifications and contributions to NCI-funded clinical trials research.
Resource Sharing Plans and Data Management and Sharing Plans are not applicable for this NOFO.
PHS Human Subjects and Clinical Trials Information form is required if human subjects research is involved.
PHS Assignment Request Form.

Evaluation Criteria

Overall Impact

Reviewers will assess the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, considering all review criteria.

Scored Review Criteria

Significance: Evaluation of the importance and relevance of the Research Specialist's contributions to NCI's mission and the cancer clinical trials enterprise.
Investigator(s): Assessment of the Research Specialist's personal accomplishments, both individually and within the context of supporting the nominating institution's clinical trials program(s). This includes qualifications, experience, productivity, and leadership.
Innovation: While not a primary focus, reviewers may consider innovative aspects of the Research Specialist's approach, acknowledging that essential projects may not always be innovative.
Approach: Evaluation of the Research Specialist's plans to develop new research capabilities and/or approaches that will improve efficiency and address novel opportunities in the institution's clinical trials program, including enhancing recruitment of underrepresented groups.
Environment: Assessment of the scope of NCI-funded clinical trials at the institution, the institution's level of accomplishments, research productivity, adequacy of NCI funding support for clinical trials, and the institution's commitment to the Research Specialist's efforts.

Additional Review Criteria (Not scored individually, but considered for overall impact)

Protections for Human Subjects: Justification for involvement of human subjects and proposed protections against research risks.
Inclusion of Women, Minorities, and Individuals Across the Lifespan: Evaluation of proposed plans for inclusion or exclusion based on sex, race, ethnicity, and age, justified by scientific goals.
Vertebrate Animals: Assessment of procedures, justifications, and interventions if live vertebrate animals are involved.
Biohazards: Assessment of potential hazards to personnel and environment, and adequacy of proposed protections.
Resubmissions: Progress made and responses to comments from previous scientific reviews.
Renewals: Progress made in the last funding period.
Resource Sharing Plans: Reasonableness of proposed plans or rationale for not sharing resources.
Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring validity of resources.
Budget and Period of Support: Justification and reasonableness of the budget and requested project period in relation to the proposed work.

Compliance & Special Requirements

Regulatory Compliance

Recipients must comply with 2 CFR Part 200, 'Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards'.
All awards are subject to the terms and conditions outlined in the NIH Grants Policy Statement.
Compliance with applicable nondiscrimination laws is required, as agreed upon during SAM.gov registration.
Mandatory Disclosure: Recipients must report any violations of federal criminal law involving fraud, bribery, or gratuity potentially affecting the federal award.
Recipient institutions must ensure that protocols are reviewed by their Institutional Review Board (IRB) or Independent Ethics Committee (IEC).

Intellectual Property

Not specifically addressed in the provided document, but general NIH policies apply.

Risk Management

NIH may terminate awards under certain circumstances, as detailed in 2 CFR Part 200.340 and NIH Grants Policy Statement.

Special Considerations

This award specifically targets clinician scientists who provide leadership and support for NCI-sponsored clinical trials, but it is important to note they are not intended to serve as principal investigators of independent research project grants (e.g., R01).
Clinical trials are NOT allowed as part of the proposed activities for this specific grant application. The grant supports the individual's role in clinical trials conducted through NCI networks, not the conduct of new trials under this award.
The R50 award must be relinquished if the awardee subsequently obtains substantial independent NIH funding (excluding R21, R03).
A change of PD/PI (Research Specialist) is NOT allowed on this R50 award.
This award provides salary and limited travel funds; it does NOT cover research expenses, which must be secured from other sources.
The Research Specialist has the option, with prior NCI approval, to move to other research programs or institutions while maintaining funding from this award.
The National Cancer Institute (NCI) seeks broad representation of institutions for this award mechanism and may consider this when making funding decisions, implying a preference for institutional diversity among awardees.
The application does not require preliminary data, specific aims, or a detailed research plan, focusing instead on the individual's accomplishments and role within the clinical trials framework.

Grant Details