All investigator-initiated new research grant
exceeding $500,000 ( direct costs
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.
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:
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.
- Contact NHLBI
National Heart, Lung, Blood Institute (NHLBI) program staff far in advance of the intended
receipt date to discuss the research idea or concept.
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
- 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) for an investigator-initiated trial).
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.
Since most new PPG and multicenter clinical trial applications
500KSpecial procedures 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.
are required for clinical trial applications with direct costs greater than $500,000
in any given year.
All requests to submit applications for Phase III
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
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.
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.
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.
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