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Q: The plan should not include stipends and trainee costs. Does this mean that there can’t be any money for post-doc compensation?
A: This is a research grant and stipends and trainee costs are not allowable costs on this type of grant. What is allowable is tuition remission costs if it is part of a compensation package. NIH does have caps on how much you can pay graduate students. In summary, you can compensate post docs and training candidates as salary, and you can also pay for supplies for their research. You can not pay for what you would normally call trainee costs.
Q: Although there are not multiple PIs allowed as center directors, are multiple PIs allowed for the RO1-type research projects within the P50?
A: Yes, you can have co-investigators for the research projects within the center. Our only concern is that there are NOT multiple NIH PIs for the overall center which would have budget implications.
Q: How might an application be perceived if it contains several research studies looking at dimensions of communication training integrated into a theme?
A: Here is my best guess as to where the reviewers would stand on this. I think the issue of training would be relevant from a program perspective if it in fact had an impact on the behaviors of people. For example, healthy behaviors that would reduce the chance that people got cancer and would help with diagnosis and/or compliance with treatment and so on. If a number of training programs were assembled that could point them directly to such an outcome and it was very well justified then I think that kind of logic would make sense. What wouldn’t work is if training for training’s sake was used as the theme for the Center.
Q: Regarding the appendix: Please indicate 1) what is allowable content and, 2) where should it go? That is, would one appendix be preferred or would it be better to have appendix materials with each project and section of the proposal?
A: The short answer is that you need a bundle of appendix material that is totally separate from the application. For example, if you had appendices for each of your three research projects, you could assemble three separate packets in the appendix for each project.
Please refer to the specific instruction that can be found on the RFA URL:
http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-08-004.html.
Q: How many new CEECRS (not renewals) would you expect to fund? Would you be surprised if the only CECCRs funded were current CECCRs?
A: We’re most likely to fund the top scoring applications. We can’t predict what will get funded in terms of new vs. old applicants because that will be up to the reviewers’ judgment. Strategically people are concerned if they should spend time and effort on this if people are already funded in the initiative. If you look across Center initiatives at NIH, statistically you’d say that somebody who is currently funded has somewhat of an advantage in terms of being able to document proof of preliminary work. However, in the previous issuance of the RFA there were a number of strong applications that we couldn’t fund. We also know that there will be more than four groups that will be strong and competitive in terms of tracking the science and what we already fund. We will explain in orientation training with the reviewers that it’s an open competition. We’ll explain that they should give all applicants clear, careful and fair consideration. One reason why we have a reissuance and make information available about who is currently funded is that no projects are perfect and no studies are without flaws. It’s not the case that the NIH community feels that what was funded previously is the absolute best science that can come in.
Q: Please discuss advantages & disadvantages of submitting an application with 3 versus 4 full projects. Can you drop one project if not well scored?
A: We can have some discretion in terms of funding after peer review. Let’s say you come in with four projects and one of them gets a poor score. Some Center initiatives in certain cases will fund a Center minus 1 project. One thing to consider is that 3 fundable projects are a minimum requirement for the Centers. If you submit only 3 R01 projects, you are taking some risk in that they’ll all sink or swim together. If you have four projects in your applications, it leaves some room for the Center to be partially funded if one of the projects scores badly.
Q: Will the indirect costs of a subcontract with another institution need to be added into the direct costs of the center budget?
A: Yes, the indirect costs for all subcontractors are added into the direct costs of the budget for the Center. Therefore, this should be reflected that way in the budget. However, even though they are budgeted as direct costs, they do NOT count towards the $1.5 million direct costs cap.
Q: Will the decision about whether a proposal satisfies the one clinical project requirement be made by NCI staff or by the peer review panel?
A: This is something that the peer review panel will determine. It will be up to us to work with the reviewers during the orientation and be very explicit with what we mean by a clinical center, but that really is a reviewer decision.
For those of you unfamiliar with the review process, it is a two-step process. First, the program staff decides if an application is minimally responsive meaning it’s in the scope of the RFA and responds to the RFA requirements. The reviewers do a more thorough assessment of relevance and potential impact.
Q: Will a site visit be a part of the final review process?
A: No, it will not.
Q: Who comprises the review team? What are their backgrounds and/or areas of expertise?
A: The adhoc committee will be developed based upon the science described in each of the applications that are received. We have the ability to recruit and tailor our committee to the specific needs of the individual applications. Therefore, we cannot say definitely who will be on the committee nor what is their area of expertise because we have not seen the applications.
Q: Are we required to build in travel expenses for mandatory annual NCI conference attendance?
A: Yes, the RFA itself has a requirement that you budget for the two CECCR meetings a year and any cross center activities. What we will probably do in implementation is put terms on the award that require attendance. That way if you have other sources of funding to support your travel you can use those rather than budget funds. The travel funds are required as a budget item so that the reviewers know and feel confident that you have made it a commitment to attend those conferences.
Q: Could you talk more about the requirements and/or expectations of the clinical setting research, which will be a required component in this application?
A: One recommendation I might make is to go and look at the Board of Scientific Advisor’s discussion about the CECCR renewal, available on http://dccps.nci.nih.gov/hcirb/ceccr/background.html
A lot of our thinking got formed in that meeting. We’re looking to create evidence in this particular investment in CECCR that can be used by people in a clinical setting. To do that, that means you’ll have to have a connection to clinical practice to make this pertinent and relevant material. Again, by looking at the BSA’s discussion, you can see what people thought about weighing different options, and what has been done previously.
One of the difficulties that people have in interpreting this is that if you’re in a different discipline, clinical means something different. To clarify, clinical means the healthcare delivery context. Also, it’s not limited to oncology care, but that could be primary care or nursing. We’re looking for at least one of these projects to test hypotheses that are directly applicable or relevant to the healthcare delivery context.
Q: What is the overall funding available for this initiative (in year 1)?
A: In the RFA it states that NCI has anticipated setting aside funds of $8 million in the first year. Having said that we never know what will actually be handed down. The reason we don’t have definitive answers on what will be spent is that Congress has not passed and the President has not signed the appropriations bill this fiscal year for the Cancer Institute. This means that NCI does not have a budget at the institute level. Therefore we do not have a budget yet for the Division level. The Board of Scientific Advisors approved that we spend up to $8 million. There is a process where we could propose later if we want to spend more, but that requires an additional decision making process within the National Cancer Institute. It is also possible that there could be less depending on the result of the current debate between Congress and the President.
Q: Suppose a center involved multiple institutions. Even though each Center can only have one PI, could co-directors/ associate directors be named from the collaborating institutions or would this not be advisable?
A: Yes, it is possible to name Co-Investigators from collaborating institutions. Programmatically, having a co-investigator with a person who is named as a co-lead is allowable and in many cases preferable.
Q: To what extent should the first proposed developmental projects relate directly to the overall theme of the proposed Center? And to what extent will NCI hope to see developmental studies that may ultimately be clinically applicable? Finally, will NCI participate in the project selection or development of the criteria used to pick developmental projects?
A: We see the value of the developmental projects as those that can take advantage of evolving technology and evidence. We would love to see a programmatic line of research where the main projects are leading to newer projects. Given that, how do you describe these first illustrative projects? We think you would be imagining the next chain of evidence from your current perspective. For example, we know you’ll be collecting an evidence base for your three main projects. We believe that there might be a next step beyond that; you will probably be able to predict what happens next if you come to a juncture in the road where you’re going to need something. Describe what happens at that juncture as a possible demonstration project. I could also see a Center saying they’re going to be a little more dependent on these types of projects and allocate more funding to them than we recommended and that is fine. What is going to be important for peer review is describing the process the Center has in place for developing and selecting such pilot projects.
Whether or not the demonstration projects are clinically applicable depends on the nature of the CECCR. It is not a requirement that any developmental projects be clinically applicable.
This is not a cooperative agreement so we don’t have program ability to dictate. We do have frequent conversations with our PIs and view this as collaborative science to a degree. We hope that discussions of science that emerge from monthly PI meetings and grantee meetings could lead to new thinking that would lead to the development of projects.
Q: Is the $1.5M direct cap escalated by 3% in subsequent years?
A: Yes, the way the RFA is written, the future years, 2-5, are limited to 3% inflation on the $1.5 million direct costs cap for the entire P50. That does not mean that different components would escalate differently than the 3%. If you build budgets that way, it’s just very important in the justification to explain why that’s so.
Q: Is there a cap on the duration of the individual projects? 3 years? 5 years?
A: No, every project in the Center does not have to be 5 years in duration. It is important to be explicit about the duration of the projects in the application and justify the budget accordingly.
Q: Could we access this video conference and question answering later? Could you please post it online?
A: Yes, the webcast is currently available here http://dccps.nci.nih.gov/hcirb/ceccr/ceccr_rfa.html
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