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Guidance for Applications with Direct Costs of $500,000 or more in any one year:
This guidance describes the National Heart, Lung, and Blood Institute (NHLBI) implementation of the NIH policy requiring all investigator-initiated applications that request $500,000 or more in direct costs in any one year to obtain documented approval from the Institute stating that it will accept the application for initial peer review.  Included in the document is a description of the process to obtain this approval and what steps the investigator must follow.  



PAR-16-037: NHLBI Clinical Trial Pilot Studies (R34)
The National Heart, Lung, and Blood Institute (NHLBI) encourages applications proposing pilot studies to obtain data that is critical for the design of robust clinical trials. This Funding Opportunity Announcement (FOA) should be used to fill gaps in scientific knowledge necessary to develop a competitive full-scale clinical trial. Appropriate pilot studies might demonstrate feasibility of an intervention or an experimental design, estimate intervention parameters, or gather other data important for the design of a trial. Applicants who propose solely to write a protocol or manual of operations or to develop infrastructure for a clinical trial will not be considered appropriate for to this announcement. Applications must demonstrate that the proposed pilot studies are both necessary and sufficient to permit the design of the clinical trial. During the evaluation of applications submitted to this FOA, the review group will also consider the significance and potential public health impact of the full-scale clinical trial that would be proposed following the R34 award period. The NHLBI anticipates that the R34 award period will yield robust investigator-initiated clinical trial grant applications for the evaluation of interventions for the treatment or prevention of heart, lung, blood, or sleep disorders.


PAR-13-128: Investigator Initiated Multi-Site Clinical Trials (Collaborative R01)
This is the program announcement to which R34/U34 investigators will respond when submitting the R01 grant applications for full study implementation. The support of multi-site clinical trials is one strategy NHLBI uses to improve the understanding of the clinical mechanisms of disease and to improve prevention, diagnosis, and treatment. The purpose of this FOA is to provide a vehicle for submitting grant applications for investigator-initiated multi-site randomized controlled clinical trials. The trials may address any research question related to the mission and goals of the NHLBI and may test clinical or behavioral interventions. The FOA is appropriate for applications to conduct phase II and phase III randomized clinical trials where participants are recruited from multiple sites. Large-scale pragmatic trials (such as comparative effectiveness trials) as well as trials designed to test efficacy of an intervention are appropriate. The trials may randomize at the individual (patient) level or at a group level (e.g., randomization of clinics, schools, worksites, etc.). Clinical trials involving NHLBI mission-related rare diseases that require coordination across multiple clinical sites are also suitable for submission to this FOA. In any case, the trial should propose the most efficient study design to complete the specific aims. For additional information about the mission, strategic plan, and research interests of the NHLBI. This FOA is not intended for support of single-center studies or multicenter observational studies that are not testing an intervention. Clinical Coordination Center (CCC) and Data Coordination Center (DCC) applications are required to be submitted together when the proposed costs of the clinical trial exceed $500,000 (minus F&A for subcontracts) in any given year.


ATHN Data Quality Counts
ATHN Data Quality Counts, through a competitive review process, provides critical funding to treatment centers to maintain secure, complete, and accurate data for the ATHNdataset. The data can be used to support research and improve outcomes.


Hemostasis and Thrombosis Research Society (HTRS) Grants
HTRS offers a variety of grants opportunities on its website. Check the website for current opportunities and submission information. Among the grant opportunities listed are: 1) Mentored Research Awards for a 2-year period for promising young investigators; 2) clinical research awards for the early phase development of collaborative clinical research projects (not currently seeking applications); 3) a new Clinical Fellowship Award;


American Society of Hematology (ASH) Awards and Grants
Each year, ASH awards more than $4 million in educational grants to benefit young scientists. Information about these grants is found on the American Society of Hematology website under awards.

 


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