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.Apply for PAR 17 268
- 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.
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Frequently Asked Questions (FAQs)
What is the Planning Grants for Clinical Trials of High Relevance to the NIGMS Mission (R34) opportunity?
This opportunity (funding opportunity number PAR-17-268) is an NIH discretionary grant that supports planning activities for a clinical trial that is highly relevant to the mission of the National Institute of General Medical Sciences (NIGMS). It is intended to help research teams prepare a trial-ready plan rather than fund the actual conduct of the clinical trial.
What is the main purpose of this R34 grant?
The purpose is to provide time and resources to create an operationally realistic, scientifically sound, and oversight-ready blueprint for a future clinical trial application to NIGMS. The focus is on building the planning infrastructure and documentation needed to improve feasibility and rigor before enrolling participants.
Does this grant pay for running the clinical trial?
No. The R34 mechanism described here supports upfront planning work and does not fund the trial itself. It is designed to strengthen readiness for a later, separate clinical trial application.
What kinds of planning activities are supported under this opportunity?
Supported activities are practical, trial-enabling tasks that typically must be completed before enrollment begins. Examples provided include:
- Writing a detailed Manual of Procedures to standardize study operations across sites and staff
- Drafting a Data Safety and Monitoring Board (DSMB) charter defining safety oversight and decision-making rules
- Developing data management and statistical analysis plans so endpoints, outcomes, and analytic methods are specified in advance
- Identifying and establishing recruitment and performance sites
- Creating training materials to ensure consistent implementation across staff and locations
- Preparing early or preliminary submissions needed for regulatory approvals
What is a Manual of Procedures (MOP) in the context of this grant?
Based on the description provided, a Manual of Procedures is a detailed document that standardizes how every site and staff member will run the study, helping ensure consistent execution across locations.
What is a DSMB charter and why is it included as an example activity?
A DSMB charter is described as a document that spells out safety oversight processes and decision-making rules for the trial. It is included as an example because formalizing safety monitoring and governance is part of making a clinical trial operationally and ethically ready.
What does the opportunity mean by “plans for data management and statistical analysis”?
The opportunity highlights creating robust data management and statistical analysis plans so that outcomes, endpoints, and analytic methods are locked down in advance. This planning helps ensure the later trial application is feasible and scientifically rigorous.
Can the grant be used to set up study sites and recruitment pathways?
Yes. The description explicitly includes identifying and establishing recruitment and performance sites as supported planning groundwork.
Can the grant support training materials for study staff?
Yes. Developing training materials to ensure consistent implementation across staff and locations is listed as an example of supported activity.
Does this opportunity support regulatory preparation work?
Yes. It supports preparing early or preliminary submissions needed for regulatory approvals, as part of planning and compliance readiness.
How does this R34 connect to a future clinical trial application?
This announcement describes a “next step” pathway: after completing the R34-supported planning milestones successfully, the applicant may submit a separate clinical trial application to NIGMS under an appropriate clinical trial funding opportunity announcement. The R34 is positioned as a preparatory stage rather than the main source of funding for trial conduct.
Is the R34 meant to improve feasibility and rigor of later submissions?
Yes. The central idea described is to fund planning work that can make a later clinical trial application more feasible, rigorous, and compliant with applicable oversight and regulatory expectations.
Who is the sponsoring agency for this opportunity?
The sponsoring agency is the National Institutes of Health (NIH).
Which NIH institute mission does the planned clinical trial need to align with?
The planned clinical trial is expected to fit squarely within the mission of the National Institute of General Medical Sciences (NIGMS), as stated in the opportunity title and description.
What types of U.S. organizations are eligible to apply?
Eligibility is described as 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 (as long as they are not higher education institutions in those categories)
- Other types of organizations as allowed under NIH rules
Are specific institution categories explicitly recognized as eligible?
Yes. The announcement 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)
- Tribally Controlled Colleges and Universities (TCCUs)
Can a foreign (non-U.S.) institution apply as the primary applicant?
No. Non-domestic (non-U.S.) entities (foreign institutions) cannot apply as the primary applicant organization for this opportunity.
Are non-domestic components of U.S. organizations eligible to apply?
No. The description states that non-domestic components of U.S. organizations are not eligible to apply.
Are foreign collaborations allowed in any form?
Yes. While the lead applicant must be domestic, foreign components (as defined in the NIH Grants Policy Statement) are allowed. This means a U.S. applicant may include certain foreign collaborations or elements when justified and compliant with NIH policy.
What is the funding activity category for this opportunity?
The opportunity falls under the Health funding activity category.
What CFDA number is associated with this opportunity?
The associated CFDA number listed is 93.859.
What is the award ceiling listed for this opportunity?
The award ceiling is listed as $100,000.
What is the funding opportunity number?
The funding opportunity number is PAR-17-268.
When was this opportunity created, and what closing date is shown?
The source listing indicates the program was created on 2017-05-03, with an original closing date of 2019-08-01.
Is this grant best understood as planning infrastructure and documentation support?
Yes. The description emphasizes that it funds planning infrastructure and documentation that turns a clinical trial concept into an executable protocol, strengthening design, governance, operational readiness, and compliance posture.
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