Planning Grants for Clinical Trials of High Relevance to the NIGMS Mission (R34) | PAR 17 268

Opportunity Information: Apply for PAR 17 268

Planning Grants for Clinical Trials of High Relevance to the NIGMS Mission (R34), funding opportunity number PAR-17-268, is an NIH discretionary grant designed to help research teams prepare for a full-scale clinical trial that fits squarely within the mission of the National Institute of General Medical Sciences (NIGMS). Rather than paying for the trial itself, this R34 mechanism supports the upfront planning work that can make or break a later clinical trial application. The central idea is to give investigators dedicated time and resources to build a trial-ready blueprint that is operationally realistic, scientifically sound, and compliant with applicable oversight and regulatory expectations, so that a subsequent clinical trial submission to NIGMS is much more likely to be feasible and rigorous.

The types of activities supported are practical, trial-enabling tasks that you typically need in place before enrolling a single participant. Examples include writing a detailed Manual of Procedures that standardizes how every site and staff member will run the study, drafting a Data Safety and Monitoring Board (DSMB) charter that spells out safety oversight and decision-making rules, and creating robust plans for data management and statistical analysis so that outcomes, endpoints, and analytic methods are locked down in advance. The opportunity also supports groundwork such as identifying and establishing recruitment and performance sites, developing training materials to ensure consistent implementation across staff and locations, and preparing early or preliminary submissions needed for regulatory approvals. In short, it funds the planning infrastructure and documentation that turns a concept into an executable clinical trial protocol.

A key feature of this announcement is the “next step” pathway it creates. After receiving R34 support and completing the planning milestones successfully, the applicant can move forward by submitting a separate clinical trial application to NIGMS under an appropriate clinical trial funding opportunity announcement. The R34 is therefore best understood as a preparatory stage that strengthens the design, governance, operational readiness, and compliance posture of a proposed NIGMS-relevant clinical trial, rather than serving as the main funding source for trial conduct.

Eligibility is broad across U.S.-based organizations. Eligible applicants include public and state-controlled institutions of higher education, private institutions of higher education, nonprofit organizations with or without 501(c)(3) status (so long as they are not higher education institutions in those categories), and other types of organizations as allowed under NIH rules. The announcement also explicitly recognizes several categories of “other eligible applicants,” including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs), reinforcing that a wide range of institution types may apply.

Foreign eligibility is limited in a way that is typical for many NIH mechanisms. Non-domestic (non-U.S.) entities (foreign institutions) cannot apply as the primary applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components, as defined in the NIH Grants Policy Statement, are allowed, meaning a U.S. applicant may include certain foreign collaborations or elements when justified and compliant with NIH policy, even though the lead applicant organization must be domestic.

Administrative details from the source listing indicate the program was created on 2017-05-03, with an original closing date of 2019-08-01. The award ceiling is listed as $100,000. The opportunity falls under the Health funding activity category and is associated with CFDA number 93.859. The sponsoring agency is the National Institutes of Health.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Planning Grants for Clinical Trials of High Relevance to the NIGMS Mission (R34)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.859.
• This funding opportunity was created on 2017-05-03.
• Applicants must submit their applications by 2019-08-01. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $100,000.00 in funding.
• Eligible applicants include: Public and State controlled institutions of higher education, Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, Others.

Apply for PAR 17 268

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