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What if my project exceeds $500,000 in direct costs in any given year?

All investigator-initiated new research grant 

Grant
financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the NIH 
National Institutes of Health (NIH)
the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers that conduct and support biomedical and behavioral research. NIH Homepage.
Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities.
applications exceeding $500,000 ( direct costs 
Direct Costs
costs in a grant or contract identified with a project or program which may include salaries, travel, supplies, patient care costs, consultant services and others.
) in any year should refer to Guidelines 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 
    National Heart, Lung, Blood Institute (NHLBI)
    a NIH Institute that provides leadership for a national program in diseases of the heart, lung, and blood as well as blood resources, sleep disorders and the Woman's Health Initiative. NHLBI Homepage.
    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 
    Data Coordinating Center (DCC)
    provides support for large studies and focuses on central training in research methods, statistical leadership, data collection and management. Also known as Coordinating Center or Biostatistical Center.
    for an investigator-initiated trial).

Since most new PPG and multicenter clinical trial applications exceed $500K 

500K
Special procedures are required for clinical trial applications with direct costs greater than $500,000 in any given year.
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 

Phase III
study to determine efficacy in large groups of people (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions, to monitor adverse effects, and to collect information to allow safe use.
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 
Award
provision of funds by NIH, based on an approved application and budget or progress report, to an organizational entity or an individual to carry out a project or activity.
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

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