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Frequently Asked Questions for RFA-HL-06-005: Network for Cardiothoracic Surgical Investigations in Cardiovascular Medicine

The National Heart, Lung, and Blood Institute (NHLBI) invites applications to participate in the Network for Cardiothoracic Surgical Investigations in Cardiovascular Medicine (Network), a cooperative network of academic centers with clinically active cardiothoracic surgeons and their colleagues in allied specialties interested in promulgating the use of evidence-based medicine in surgical practice. The goal of the Network is to foster a culture of rigorous scientific comparisons and promote the evaluation of newer surgical techniques, technologies, devices, and innovative pharmaceutical and bioengineered products directed at cardiovascular disease. The Network will allow research teams led by cardiac surgeons to evaluate, by the most rigorous methods possible, newer therapies and techniques as they move from laboratory science to broad clinical use. The Network will enhance the capacity to disseminate study results, and translate findings to large scale trials or practice. The program will provide support to maintain the necessary infrastructure to develop, coordinate, and conduct multiple collaborative proof-of-concept clinical studies and interventional protocols to improve cardiovascular disease outcomes.

Pre-Submission Meeting:

A pre-submission meeting will be held on Wednesday May 3, 2006 from 12-2 at the Philadelphia Marriott, Room Salon K(fifth floor), 1201 Market Street, Philadelphia, PA at the AATS American Association of Thoracic Surgeons Meeting. There will be presentations by National Heart, Lung, and Blood Institute Program, Review, and Grants Operations staff and an opportunity for potential applicants to ask questions about the RFA.

For further information contact:

Marissa Miller D.V.M., M.P.H.
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Dr.
Rockledge II, 9180
Bethesda, MD 20892
Telephone: (301) 594-1542
FAX: (301) 480-1336
Email: Millerma2@mail.nih.gov

Questions for April 2006:

Q: How is a "single institution" defined? Does it have to be one hospital or can it be a surgical practice in which surgeons operate at multiple hospitals?
A: An institution applying as a Clinical Center site can be a single institution, or a collaboration among a group of institutions. The collaboration must be described and supported with letters of collaboration and/or other evidence of affiliation and intent to work together. An application will be considered non-responsive if it cannot demonstrate at least 500 major cardiac surgical procedures per year. These procedures can be distributed among the group of collaborating institutions. Please note the basis for this endeavor is multicenter collaborative clinical research. Participation of surgeons and allied health professionals is essential.

Q: The RFA states that an applicant must submit at least two protocols. Are there a maximum number of protocols that can be submitted in an application?
A: Only the first two protocols presented will be reviewed.

Q: Where should the protocol budgets included in a Clinical Center application be placed and do they count toward the 25 page limit?
A: A budget for each proposed protocol should be included with each protocol write-up in the research plan of the application. These are separate and distinct items from the core budget costs for the CC. The protocol budget information does count against the 25 page limit for the research plan. The main budget pages of the application should describe infrastructure costs only.

Q: For other NHLBI projects we have worked on, it was recommended that we attempt to obtain additional support from industry to offset some of the costs. I know that these proposals are ones that are unlikely to be supported independently by industry, but what about supplemental funding support?
A: If the protocols you will be submitting would benefit from Industry collaboration, including industry financial contribution, you should describe this potential collaboration and document any commitment you have obtained from industry, recognizing that successful application to participate in the Network does not guarantee that any protocols will be performed by the Network. The decision to develop protocols for the Network will be made by the Steering Committee as a whole.

Q: The application guidelines say for a Clinical Center site the PI must commit to at least 10% while a single Co-I must commit to at least 30%, would NHLBI accept an alternate division of labor, or to share the Co-I effort across two investigators?
A: The percent efforts specified in the RFA for Cardiothoracic Surgical Investigations are minimums that the National Heart, Lung, and Blood Institute deem are necessary to run the Network activities based on our experiences from other Institute Networks. The Peer Review panel will compare your proposal to our benchmarks. Higher percent effort levels can be proposed.

Q: Can a non-profit 501 (c) 3 Foundation that conducts cardiovascular research and is affiliated with a private practice group of cardiologists and cardiac surgeons apply as a Clinical Center to this RFA?
A: If the minimum criteria of 500 major cardiac surgical procedures per year are met by a non-profit or private practice group, they are welcome to apply to this RFA. The experience in conducting and participating in trials is also very valuable and is necessary for an application to be competitive. The willingness to collaborate within the Network is also important to a successful application.

Q: Can staff be named on both an application for a CC and a DCC?
A: There is nothing precluding an individual, other than the PI, being named on both a CC and DCC application. However, the issue of maintaining objectivity in regard to analysis of the data collected from the clinical site could arise during the review of applications. Our guidance would be for the Institution to address separation of responsibilities and how this staff member would remain objective in the application.

Q: Do you have to be a Clinical Center site in order to bring a novel therapy or device to the Network to be tested?
A: No, once the Network is established there will be a process developed to consider protocols from investigators outside the Network, it is anticipated that protocols developed by the funded Clinical Centers will be considered first and foremost.

Q: Do I read the RFA correctly to state that only a surgeon will be P.I. at each site?
A: For Clinical Center applicants a surgical Principal Investigator (PI) is required. The Co-Investigator must be a physician, but can be from another specialty such as cardiology or anesthesiology, among others. A minimum of 10% effort for the surgeon PI was set due to the fact that this person's role is likely to develop support for the protocols among the collaborative group ultimately involved in conducting the studies or trials. This could involve convincing cardiologists, pulmonologists, anesthesiologists and others to work together collaboratively. The 10% effort is a minimum that would be considered responsive to the RFA, taking into consideration the seniority and other time commitments of this individual.

Q: Is NHLBI envisioning a network, or several networks? Are pediatric cardiovascular networks also considered?
A: This is envisioned as one Network comprised of up to seven Clinical Centers and one Data Coordinating Center. The focus will be on adult populations, although a small number of children may be included depending on the design of the particular protocols that are run by the Network. The National Heart, Lung, and Blood Institute supports a separate Network focused on children, the Pediatric Heart Network. All sites are expected to participate in all Network protocols.

Q: Generally speaking, are applications weighted toward experienced investigators, innovative ideas, multidisciplinary approach, etc.?
A: NHLBI has found Networks to be an efficient means of conducting multiple multi-center studies in a relatively short period of time on defined patient populations. Past experience has shown that, in order for a Network to be effective, Clinical Centers must be able to work cooperatively within the Network, to recruit and retain patients into protocols, to produce quality data in a timely fashion, to have an established research team to conduct studies and to provide support for Network activities. Therefore, the quality of the research team and the institution as well as proof of ability to participate in multi-center clinical research will be important criteria when considering a site for Network participation, as are innovative ideas and a multidisciplinary approach.

Q: If my Institution is awarded a Clinical Center grant, am I assured that the protocols proposed in our application will be conducted in the Network?
A: Similar to other NHLBI Networks, protocol proposals requested in this RFA are intended to provide evidence of knowledge of the design and conduct of multi-center clinical studies. However, it should be noted that there will be a process for selecting protocols for further development once the Network is up and running. The process will take into account the strengths of the clinical sites participating, the scientific importance of the question, and feasibility, so only those considered of the highest importance are likely to go forward. Therefore, not every protocol proposed by every successful applicant will be conducted within the Network. Some protocols conducted by the Network may not be from the original applications.

Q: Is there an expectation to create 'core' laboratories for analyzing potential surrogate markers of responsiveness in this Network and for potentially analyzing genetic traits that might predict for responsiveness to particular interventions?
A: The specific protocols will drive the need for core laboratories to support the research question. Core labs for the Network would be sub contracted by the DCC. Money for core labs would be part of dollars set aside to conduct protocols. The cores, if any, depend on what protocols are actually conducted by the Network.

Q: Can I apply for both CC and DCC?
A: Yes, an institution can apply for both DCC and CC as separate applications, with distinct PIs. However, the DCC must be impartial and should not be involved in recruitment of patients. Institutions that expect to apply as both a CC and a DCC have the burden to establish a firewall between its CC and DCC investigative teams.

Q: Are individual researchers to submit an application for their specific project or is the institution to submit an application defining its role as a CC?
A: The institution should submit an application defining its role as a CC. Two sample protocol proposals are a required part of that application.

Q: Would the consortium consider protocols that test new devices?
A: Yes, although final protocol development and selection will be the responsibility of the Steering Committee.

Q: Should the required two (2) protocol proposals be submitted as a part of the Clinical Center application in the PHS 398 format, or should they be submitted separately?
A: Protocol proposals must be submitted as a part of the Research Plan in the required PHS 398 format. Each of the two (2) protocol proposals should be followed by a budgetary proposal that is specific to the cost of the proposed project, recognizing that actual Network protocol funds will be distributed by the DCC to the participating CCs on a per-capita basis. The detailed budget section of the CC application should refer to the yearly cost of the local infrastructure.

Q: Should the two (2) protocol proposals be limited to the resources available at one CC, or should they be proposed on a network scale?
A: In order to eliminate supposition regarding the resources available to other potential CCs, the RFA stipulates that the two (2) proposals be written in terms of the resources available within the local Institution and any collaborators with that Institution, but could potentially be used in the Network environment and be conducted in a 2-3 year time frame.

Q: What is required in a letter of intent?
A: The letter of intent should identify a PI, the primary institution, and any associated collaborating institutions. The letter should also state whether or not the applicant will apply as a CC or DCC. Further inquiries regarding requirements for Canadian centers should be directed to Ms. Hines-Reimer. (ehinesreimer@cihr.gc.ca).

Q: May one institution submit two CC applications under two different PIs?
A: No, if more than one application is received from a single institution the applications will be deemed non-responsive.

Q: What CVs or biosketches need to be enclosed?
A: An NIH-type CV should be included for all key investigators.

Q: Do applicants need to submit a detailed budget for the Training Core?
A: Yes, a detailed budget for an amount not to exceed $100K in direct costs is required. The budget should list personnel, travel, and other training related expenses.

Q: For the $250K direct cost CC budget, can the applicant submit it in a modular format? i.e., named individuals with % effort, but no actual dollars?
A: No, the RFA does not allow use of the modular budget format.

Q: In a CC application, what information is included in the 25 page limit?
A: The Research Plan including items A-D, an overview page, descriptions of the two protocols and the protocol budgets together are not to exceed 25 pages. An additional 4 pages can be used if a skills development core is proposed.

Last updated: April 21, 2006

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