Frequently Asked Questions for the NHLBI Cardiovascular Outcomes Research Centers and Coordinating Unit (U01) RFA HL-10-008 and RFA HL-10-018
Q. Which RFAs are part of the NHLBI Cardiovascular Outcomes Research Centers and Coordinating Unit?
A. The following RFAs participate in this program:
Q. Will there be an online technical meeting for these RFAs?
Yes, a Webinar was held for these RFAs on Wednesday, December 9, 2009 at 1pm Eastern Time. The web address for viewing a recording of this Webinar is located at https://webmeeting.nih.gov/p29614693/. The slides from this presentation can be downloaded from on the viewing website on the left side of the screen.
Q. What is the U01 (cooperative agreement) mechanism and why are these Centers and Coordinating Unit being funded as U01s?
A. The U01 mechanism allows for a partnership between the NIH and the teams of researchers who will comprise the Centers funded through this RFA. Under the cooperative agreement mechanism, the NIH supports awardees' activities by working jointly with them to ensure fulfillment of programmatic goals; however, prime responsibility for the conduct of the research resides with the awardees. Given the nature of collaboration requested across Centers and RCU with this RFA, it was thought that substantial NIH programmatic involvement and support would be important to enable successful completion of project goals.
Q. How is “outcomes research” defined for purposes of these RFAs?
A. The definition of outcomes research used in this FOA is very broad and involves research defined as applied clinical research that generates knowledge to improve clinical decision-making and health care delivery to optimize patient outcomes. Outcomes research is not defined by a particular methodology, but rather its objective – the study of approaches to improve patient outcomes from health care delivery. This type of research can employ natural experiment designs, quasi-experimental approaches, or experimental approaches such as randomized trials at the group level.
Q. Are existing Cardiovascular Outcomes Research Centers funded through other non-NIH mechanisms eligible to apply for this Centers Program?
A. The purpose of this RFA is to establish three Centers for Cardiovascular Outcomes Research (CCOR) that will complement and collaborate with other existing centers. However, existing cardiovascular outcomes research centers are eligible to apply as long as the scope of work or specific aims for the proposed projects are distinctly different from existing projects and the PI has appropriate availability of time to participate in both efforts. Additionally, there are several roles that an individual can take in a CCOR - the overall PI of a CCOR, PI on a project within a CCOR, or co-investigator on any project within a CCOR. Investigators from existing centers can participate in the NHLBI Centers in any of these potential roles given the conditions above regarding scope of work and available percent effort.
Q. Are Center proposals with projects engaging a pediatric population considered responsive to the RFA?
A. Yes, cardiovascular outcomes research involving pediatric populations would be considered responsive to this RFA.
Q. Is it OK to have a virtual Center, rather than have all the investigators for the Center located at the same university?
A. Yes, it is permissible to have a "virtual" Center spread across multiple institutions. In fact, we expect this to be a possibility, but it is not a requirement. We recognize that the expertise required for the kind of interdisciplinary research solicited in this RFA is not always available within a single institution.
Q. Can more than one group at the same university apply for this grant?
A. Yes, more than one applicant or group of applicants can apply from the same institution.
Q. Can an individual participate or collaborate on more than one application?
A. Yes, as stated above, there are many roles that an investigator can take within a Center – the overall PI of a Center, PI on a project within a Center, or co-investigator on any project within a Center. Investigators can participate on more than one application, but cannot submit more than one application as the overall PI of a Center.
Q. Are foreign scientists and institutions eligible?
A. No, foreign organizations are not eligible to apply.
Q. Is it intended that Center applicants will propose several, concurrent studies in different but related topic areas, similar to Program Project Grants or PPGs?
A. Unlike a PPG in which researchers attempt to better understand several facets of a particular topic area, the intent of this RFA is to conduct cardiovascular outcomes and comparative effectiveness research that focuses on patient and clinical-relevant outcomes of healthcare and the determinants of these outcomes. While the research projects do not require multiple studies on different topics that are conducted simultaneously (as would be expected in a PPG), they should be complementary and leverage the expertise and resources of the Center. The expectation is that studies can occur sequentially or concurrently, depending upon the scope and timeline of the proposed projects.
Q. Is there a required number of studies for each Center?
A. The RFA requests that each Center conduct 1-2 studies dependent upon the size, scope and timeline of the projects proposed within the budgetary constraints described in the RFA.
Q. Are there requirements or constraints in terms of the outcomes studied by projects responsive to the Centers RFA?
A. Yes, responsive projects should focus on outcomes of cardiovascular mortality, cardiovascular clinical events, cost-effectiveness, or patient-related quality of life. However, for primary prevention studies or studies of young or pediatric populations, the study period (4 years) may not be sufficient to reach primary endpoints such as mortality or clinical events. In this situation, intermediate outcomes with a correlation to mortality or clinical events (e.g., risk factor reduction) along with cost-effectiveness or quality of life outcomes would be permitted. Mortality or clinical events could be evaluated as secondary outcomes in this scenario.
Q. Can randomized trials be proposed for the Centers award?
A. Yes, trials that randomize at the group or practice level can be proposed. However, drug efficacy trials or trials that randomize at the patient level are not appropriate responses to this RFA.
Q. Are Center applicants required to include cores, such as biostatistics, training, and management cores, in their applications, as is often the case with Centers projects?
A. Cores are not required, and we do not expect applicants to propose them.
Q. How do you define “Early Stage Investigator”?
A. In general, a New Investigator is an investigator who has not previously competed successfully as PD/PI for a significant NIH independent research award. An NIH Early Stage Investigator (ESI) is an investigator who qualifies as a New Investigator and is within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent). See http://grants.nih.gov/grants/new_investigators/ for the definition. The intent of including an Early Stage Investigator in this RFA is to provide opportunity to propel forward the career of an individual appropriately trained for a career in cardiovascular outcomes research. In general an ESI that might participate in a Center grant would be an individual who has completed the bulk of his/her research training and would be at the stage of preparing to compete for an independent investigator award.
Q. What is expected regarding the faculty development plan in a Center application?
A. In order to bolster the pipeline of investigators pursuing cardiovascular outcomes research, we have included a component of faculty development within these Centers. It is expected that each Center application will identify at least one Early Stage Investigator to participate as a PI, co-PI or collaborator on a project within the Center. Center applicants will need to briefly describe plans for mentoring this individual and developing his/her career as a cardiovascular outcomes researcher. This information should be included in the Research Plan section of the PHS 398 application. Opportunities to network, attend conferences and meetings should be discussed. A full description of training and environment as one would provide in a career development award is not required for this application.
Q. Early Stage Investigators are targeted for faculty development in the Centers RFA. Can an ESI concurrently hold a K award and participate as an investigator on a Center project?
A. In general, an ESI who is part of a Center award would not be able to concurrently hold a K award because the K award limits Public Health Service (PHS) salary support for the duration of the K award. For further specific questions related to concurrent training awards and Center involvement, please contact the Program Office for this RFA or the training office that administered the K award.
Q. Do I need to submit the application via paper format?
A: YES. Please use the PHS 398 research grant application instructions and forms.
Q. What is the page requirement for the Outcomes Research program?
A. The page limitation for the Research Plan section of the Research Center application is 25 pages or less. The page limitation for the Research Plan section of the Research Coordinating Unit is 15 pages or less. This Research Plan will not be subject to the restructured application format that takes effect on January 25, 2010.
Q. Is more than one PHS 398 form needed – one for each of the projects or studies proposed in the Center? Or is one PHS 398 form to be used for all studies proposed?
A. Only a single PHS 398 form with the standard 25 page Research Plan section is needed. The 1-2 proposed studies should be described in one 25-page Research Plan section.
Q. Does the Center application have full background, methods, statistical analysis plans, etc. for each project included in the Center proposal?
A. The overall background should have a coherent narrative that justifies the studies you are proposing and how they are complementary and leverage the expertise and resources of the Center. In terms of the specific background, methods, and analytic plan for each project, you need to provide enough detail so that reviewers can understand what you plan to do and how you plan to evaluate your progress at each step (i.e. milestones/criteria met). If there is overlap in background, methodology, and analytic plans, we would encourage you to find ways to streamline redundant sections so that you maximize the pages allotted for meaningful information.
Q. Do Center applicants have to submit a proposal for a Resource Coordinating Unit (RCU) and do RCU applicants have to submit a proposal for an Outcomes Research Center?
A: No, it is not mandatory that a Center applicant propose an RCU or that an RCU applicant propose a Center. However, Center applicant institutions are strongly encouraged to submit an application for an RCU along with their application for the Center. The Center applications and the RCU applications will be reviewed independent of one another.
Q. How do I apply for an RCU?
A. To apply for an RCU, please see RFA-HL-10-018 for details of the application.
Q. Do we submit a separate application for the RCU?
A: Yes. See above.
Q. Do we submit a separate budget for the RCU?
A: Yes, please see above.
Q. Is the PI of the Center also the PI of the RCU, or can/should that be a different person?
A. The PI for these 2 components should be different since the functions of each are quite different. For example, a biostatistician or senior expert with remarkable leadership skills may consider being PI of the RCU, as the RCU will have a substantial role in coordinating collaborative efforts across all Centers. However, the PI of an individual Center would function to lead and conduct the individual research projects within a Center. Thus, the expertise of the Center PI would, for example, be an experienced investigator in outcomes research with leadership skills to coordinate a multidisciplinary team to conduct the research projects proposed.
Q. Can we propose more than one PI or multiple PI’s for the Center or RCU application?
A. Yes, Co-PI’s or multiple PI’s are permissible for both the Center and RCU RFAs. It is recommended that this approach be justified, and that applicants provide the additional information outlined in Section IV.2 of the RFA.
Q. If we choose to submit an RCU application along with the Center application, is it possible to be awarded a Center but rejected as the RCU?
A. Yes. Additionally, the opposite can occur, i.e., one can be awarded as the RCU but not as a Center.
Q. Since NHLBI will be forming an OSMB/DSMB, does that mean that the application for a Center does not have to include an OSMB/DSMB as would be the case in an R01?
A. That is correct. The individual research applications should not include language or budgets for OSMB/DSMB members. The travel, honoraria & other expenses for OSMB/DSMB members will be covered by the Research Coordinating Unit (RCU). If you plan on submitting an application for the RCU (and we are strongly encouraging applicants to consider doing so), estimates of costs for an OSMB/DSMB should be included in that budget (please budget for one in-person and one teleconference meeting per year for 4 board members). While you may describe the type of expertise that you believe should be included in the OSMB/DSMB, please do not nominate specific members for a proposed OSMB/DSMB or other advisory groups, once an RCU is selected, NHLBI will work with the RCU and the other funded applicants to generate a list of possible OSMB/DSMB members, from which NHLBI will select the OSMB/DSMB members.
Q. What other meeting-related travel expenses should applicants include in their budgets?
A. In addition to travel to OSMB or DSMB meetings (as noted above), each awardee will be required to attend three in-person Steering Committee meetings the first year, and two in-person meetings per year thereafter. Applicants should assume for budgeting purposes that the meetings will be for two days in the Washington, DC, metro area and will require the attendance of at least the Principal Investigator(s). Investigator and ESI/trainee meetings will be held yearly around one of the Steering Committee meetings. Applicants should budget for one additional day in the Washington, D.C. metro area yearly for this meeting. Center applicants should include in the budget travel for key investigators including Early Stage Investigators. If you plan on submitting an application for the RCU, estimates of travel costs for RCU personnel to attend each of these meetings, as well as costs for securing meeting space, should be included in your RCU budget. RCU budgets should not include travel costs for Center personnel, since these costs will be included in Center applicants’ budgets.
Q. How should I structure the budget?
A. Structure your budget as you would structure an R01 budget that involves multiple studies. Your business office can provide additional details regarding budgetary and grants management questions. After consulting with your business office, if additional information is needed, please contact the following NHLBI grants management staff:
Q. What is the budget cap? How many years can I ask for?
A. For a research project: $920,000/year (direct costs) for a maximum of four years. For an RCU: approximately $500,000/year (direct costs) over four years. Please note that the direct cost limitation does not include Facilities and Administrative (F&A) costs requested by consortium participants.
Q. When is the Letter of Intent (LOI) due? Are LOIs required?
A. The LOI receipt date is December 21, 2009. Although LOIs are not required, the information in the LOI will assist NHLBI in planning the review and in identifying responsiveness issues at an early stage.
Q. What should be covered in the LOI?
A. The following pieces of information will be extremely helpful for NHLBI staff in setting up the most adequate review for your application:
Q. Is this RFA expected to be reissued in 2010?
A. No, a reissuance of this RFA is not expected.
For more information, please contact: