What if my project exceeds $500,000 in direct costs in any given year?
All investigator-initiated new research grant applications
exceeding $500,000 ( direct costs ) in any year should refer
for Applications with Direct Costs of $500,000 or More in
Any One Year for specific details and guidance on this process. The following steps summarize what is required:
- Contact NHLBI program staff far in advance of the intended
receipt date to discuss the research idea or concept.
- A staff visit (either in person or by phone) must be
scheduled 2-3 months in advance of the intended receipt
date. NHLBI staff will include a representative from
the Program Office and Review Branch. The Program
Director will help you determine, based on the nature of
your proposal, who should be included to represent the
investigator team. The staff visit will provide you with
guidance with respect to whether NHLBI may be willing to
accept the application, what information is needed prior
to receipt of the application, and the application submission
and review process. (This Checklist may help you prepare for the staff visit)
- You must submit a letter
to the Director
of the Division most relevant to the proposed research,
requesting approval to submit an application to NHLBI
(see Guidelines for Applications with Direct Costs of $500,000 or More in Any One Year for specific guidance). The
request should generally be no longer than 5 pages but
must provide sufficient information about the specific
aims of the research (including subprojects), the significance
and/or potential impact on public health or health care
of the research, annual and total direct costs and total
costs, and key investigators to enable the Institute to
make an informed decision about whether or not to accept
a proposed application.
- • All multi-site randomized controlled trials with direct costs of $500,000 or more (excluding consortium F&A costs) in any year must include plans to submit at least two applications, one of which is for the support of a Clinical Coordinating Center (CCC) and the other which is for support of a Data Coordinating Center (DCC) (The Compendium of Best Practices for Data Coordinating Centers may be used as a tool for clinical researchers who need to identify a DCC for an investigator-initiated trial).
Since most new PPG and multicenter clinical trial applications
exceed $500K in direct costs in one or more years, applicants
must contact Institute staff to discuss the study and schedule
a staff visit. For renewal or supplemental applications,
applicants must also contact Institute staff for guidance
on pre-submission requirements.
All requests to submit applications for Phase III clinical
trials with direct costs greater than $500,000 in any given
year must include plans to submit at least two applications,
one of which is for the support of a data coordinating center
( DCC ). The principal investigator for the DCC cannot be involved
in (and cannot be a principal investigator on) any other
award associated with the trial. In assessing whether
the budget is greater than $500,000, the budgets for the
two applications are combined, not considered separately.
Additional information may be found in Guidelines for Investigator Initiated Multi-Site Clinical Trials.
There are additional considerations for applications with direct
costs that are greater than the allowable PPG budget cap in
any year (see Allowable
Requested Direct Costs For Program Projects). Requests
to submit these applications will only be considered by the
NHLBI once a year. Full and complete requests,
including budgetary Information, must be received by the Institute
by November 15 to be considered.
Page Last Updated: November 2011
Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov