Frequently Asked Questions for RFA-HL-11-008: Translational Research Centers in Thrombotic and Hemostatic Disorders (TRC-THD)

Q: How does the Specialized Center Cooperative Agreement (U54) differ from the Specialized Center (P50) mechanism?
A: A cooperative agreement is an assistance mechanism in which there is substantial NIH programmatic involvement. The details are outlined in the RFA announcement Section VI, 2.

Q: Can a TRC-THD have more than one Principal Investigator (PI)?
A: Yes. A TRC-THD may have more than one PI. However, each PI must contribute 25% effort to the program.

Q: Can a research project in a TRC-THD have more than one Project Leader (PL)?
A: Yes. A research project in a TRC-THD may have more than one PL. However, each PL must contribute 20% effort to their project.

Q: Can a TRC-THD have foreign consortia?
A: Yes. A TRC-THD may contain foreign consortia that have specific relevance to the objectives of the program and provide a special opportunity for proposed research.

Q: Do all TRC-THD applications need to include a proposal for the Administrative Coordinating Center (ACC)?
A: Yes. Every application must include a proposal for the ACC. The proposal should be prepared as a separate section containing the description and budget for the ACC. The ACC section will be scored separately from the remainder of the TRC-THD application.

Q: Is the budget for the ACC included in the $1.8 million per year direct cost cap?
A: No. The ACC budget of up to $150,000 per year direct cost is separate from the budget cap for the TRC-THDs.

Q: What do you mean by early phase translation research?
A: Early phase translation research is meant to comprise a wide range of research studies that are beyond the discovery phase and before the Phase III clinical trial. It refers to research that supports the clinical potential of the discovery, such as testing in animal models of the disease, evaluation in humans/human samples of disease state versus controls, validation in a second set of human samples and small early phase clinical study.

Q: Must the “assay, method, procedure or agent in early phase translation” be ready for translation at the time of application submission or can it progress to that stage during the course of the grant period?
A: There must be at least one assay, method, procedure, or agent that is in early phase translation at the time of submitting the application. The application may also contain other research directions or alternative approaches that are still in the discovery phase.

Q: What do you mean by “junior faculty”? Do they need to qualify as an NIH defined “Early Stage Investigator” (ESI)?
A: The term “junior faculty” generally refers to Assistant Professors or the equivalent. They may but are not required to meet the NIH definition of ESI.

Q: Why must there be collaboration with a CTSA or comparable institutional program?
A: The objective of requiring collaboration with a CTSA or comparable program is to maximize resources and avoid duplication. CTSAs offer a variety of resources and services that should benefit a translational or clinical research program. In addition, many institutions have existing programs with similar capabilities. Investigators should explore the resources available at their institutions when developing their TRC-THD program.

Q: Can the budget include costs for utilization of CTSA or other institutional programs?
A: Yes. The costs to utilize the resources and services of these programs can be included. It is expected that there will be a savings in costs and time in collaborating with existing programs.

Q: Should the TRC-THD propose an External Advisory Committee in addition to the Internal Advisory Committee as generally done for Program Project Grant applications?
A: No. The TRC-THD application should only include an Internal Advisory Committee. An External Review Panel will be established by the NHLBI for the entire program.

Q: Should the costs for attending the annual investigators meeting in Bethesda be included in the application? Who should attend?
A: Yes. The costs for attending the two day annual investigators’ meeting in Bethesda should be included in the application. The Principal Investigator(s), all Research Project Leaders and the Translational Research Skills Development Core Leader must attend the annual meeting. Additional members of the research team are welcome to attend and attendance of research fellows and junior faculty is encouraged.

Q: Will there be any special aspects to the review of the TRC-THD applications?
A: The review and selection process is outlined in Section V of the RFA announcement. An appropriate peer review group will be convened by NHLBI. Each application will be reviewed in its entirety and receive a single impact/priority score. The individual research projects will not receive separate scores. The ACC component will be scored independently from the rest of the TRC-THD application. Specific questions related to the TRC-THD program have been added to the scored review criteria. Criteria for the review of the Translational Research Skills Development Core and the ACC are defined in the announcement.

Project Officer:
Rebecca P. Link, Ph.D.
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
Rockledge II Building, Room 9168
6701 Rockledge Drive, MSC 7950
Bethesda, MD 20892-7950
Tel 301-435-0071
FAX 301-480-1046

Last update: October 2010

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