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February 15, 2008
Q: The RFA does not list any special requirements around the Appendix Materials other than the NOT-OD-07-018 guideline. Because this is a P50, can we submit more than the three allowable publications? Also, where are the Appendix materials required to be? For the sake of organization, can we include them after each applicable section in the research plan?
A: Here are the important points to consider regarding appendix materials:
- URLs need to be used when they are available. These can be placed in the Literature Cited or within individual Biosketches.
- No more than 3 papers per research project. These must be limited to publications that are without a URL or are in press manuscripts. Manuscripts under review are not acceptable.
- Appendix items must NOT be placed in the body of the application. Dividers or section pages can be used in the appendix to delineate which items align with individual projects.
- For submission of appendices in .pdf format: In this case the use of folders on the CD or bookmarks within a unified .pdf file can be used to delineate the projects to which specific items apply.
February 11, 2008
Q: Can we have one year that is over the annual budget if we do not exceed the total amount of $7.5 million across all years?
A: We are not able to write an ARA to allow a PI to go over the stipulated amount as we are with an R01; given that, the direct cap cost is quite firm. The first year in particular will be closely scrutinized. My advice would be to keep your budget under the cap and try to plan to have some carryover from the years where less money is spent to fund years where you might need more. Carryovers are allowed as long as they are not outrageous and give us cause to wonder how much research is actually being done.
Q: Other kinds of Centers are expected to spend 100-150K EACH year on developmental projects. For budget reasons, we were not going to do that each year. Would you advise we try to have developmental projects annually and try to budget accordingly?
A: The amount of budget you want to commit to developmental projects is entirely up to you. I would consider the nature of the science in which you are involved (are there unknown trajectories that need nimble positioning with new projects?), the overall themes of the Center (big intervention vs. incremental programs of discovery), and the processes you set up to select the developmental projects.
January 25, 2008
Q: The RFA notes that there should be a section devoted to "Developmental Projects" as well as a section for the "Training and Career Development Program." Is it allowable to combine these two sections in our submission if we are planning for the two programs to work together under one Core? We will stay within the specific page requirements for the two sections in our description of this Core.
A: That seems like an imminently reasonable approach. Be sure to put an introductory sentence explaining that you are combining the sections and why, primarily to be sure that reviewers understand you are being responsive given the thematic.
January 22, 2008
Q: Is it true that an application to NCI, which seeks more than $500K per annum, needs a letter of approval attached to the application?
A: This question has to do with whether or not NCI is requiring an ARA (Awaiting Receipt of Application) form for the CECCR II proposals. The answer is "no." Since the RFA represents a set-aside budget, we know to expect proposals that will come in well over the $500 K threshold required for ARA’s.
January 17, 2008
Q1. Each full research project requires a face page, project summary and key personnel pages. Are those pages in addition to the 22 page limit or do they have to be part of the 22 pages? Are biosketches included in this page limit?
Q2. Part 1. Regarding the page limits for the full projects: I understand from reading the QandA section on the website that the 22 pg. limit is “all-inclusive” meaning the face page, abstract/key personnel and A-D are all limited to 22pages. Correct? (Exceeding this limit disqualifies the application?) And this excludes the reference list, enrollment table, Human Subjects, etc. Right?
Part 2 . Am I correct that reference lists throughout the six sections can be separated by section/project/ and do not count in the page totals?
Q3. My questions below are regarding the "Individual Full Research Projects" (generally, their placement within the larger submission and specifically, Biosketches and Sections E through L of the PHS398): For the Individual Full Research Projects, where do you expect the biosketches for Key Personnel and sections E through L (PHS398) to appear/be placed appropriately within the full body of the application? There are biosketches for the Administrative and Other Cores as well as for the R01-type projects. For example, do you want ALL of the biosketches (for the Cores and research projects) to appear immediately after the budget pages or should they appear with each separate R01-type project? And do you want each respective E-L section to follow each Research Plan (A-D)? Would it be appropriate to address "Section 3. Individual Full Research Projects" in this way: Please refer to Appendix A for the complete, full applications for the research projects. Therefore, Appendix A would be many pages but easily portable for parsing out to reviewers.
These Questions were referred to a Scientific Review Officer to offer his interpretation.
Answer to all (1, 2 and 3): Note: PHS 398 instructions Rev. 09/2004 apply (not the latest release that will become mandatory in May 2008). These three questions beg for further clarification of the required application structure and page limits. The RFA requires variation in structure from the PHS 398 structure in regard to the “Research Plan”, and as such all other parts of the application should be unified and without page limit restriction. At the risk of adding further confusion here is the structure that I, a reader and not author of the RFA, interpret from Section IV. 2. of RFA-CA-08-004; assemble the application as follows:
- Face Page (PHS 398 Form Page 1)
- Description, Performance Site(s), Key Personnel (List all, including all key project personnel), etc. (PHS 398 Form Page 2)
- Table of Contents (PHS 398 Form Page 3) Modify this in a manner that is appropriate to the structure of the sections that follow.
- Budgets:
- the Overall budget
- Year 1 Itemized budget (using Form Page 4)
- Cumulative Budget for all years (using Form Page 5)
- Justifications that are relevant to the line items on the Overall Budget pages
- Administrative Core Budget
- Year 1 Itemized budget (using Form Page 4)
- Cumulative Budget for all years (using Form Page 5)
- Justifications that are relevant to the line items on the Overall Budget pages
- Research Project 1 Budget
- Year 1 Itemized budget (using Form Page 4)
- Cumulative Budget for all years (using Form Page 5)
- Justifications that are relevant to the line items on the Overall Budget pages
- Research Project 2 Budget
- Year 1 Itemized budget (using Form Page 4)
- Cumulative Budget for all years (using Form Page 5)
- Justifications that are relevant to the line items on the Overall Budget pages
- Research Project 3 Budget: First Year and Cumulative Budgets and Justification in the same pattern as above. Repeat as necessary for additional projects
- Developmental Projects: First Year and Cumulative Budgets and Justification as above (note: A single, unified budget should be presented for all DPs, regardless of the number of developmental projects that are proposed for support under the award).
- Shared Resources Budget 1: First Year and Cumulative Budgets and Justification as above
- Shared Resources Budget 2, etc.: First Year and Cumulative Budgets and Justification as above. Repeat as necessary for additional Shared Resources.
- Training or Career Development Budget: First Year and Cumulative Budgets and Justification as above
- Biographical Sketches: Following the order listed on Form Page 2, place the biosketches for all Key Personnel (regardless of whether they are key to several projects, cores, etc., or whether their role is specific to only one project).
- Resources
- Research Plan Now follow the instructions in the RFA
- Instead of Sections A-D, Sections 1-6. Sections 1, 2, 4, 5 and 6 should be 40 pages or less. Any multiples of Section 3 represents additional pages but each has its limits and required structure.
- Section 1. Overall Description
- Section 2. Administrative Core
- Insert Multiples of Section 3 here. Each Section 3 should be no more than 22 pages consisting of the following
- On the first page of each Section 3 Research Project, Include:
- Title
- Project Leader Name
- Project Summary
- List the Project Key Personnel indicating the percent effort that each named person will commit to the Project.
- On the remaining space in the allowable 22 pages allotted to each Section 3, provide a Project Research Plan (equivalent to PHS 398 Research Plan Sections A-D. Note. Relevant budget, biographical sketches and resources are placed elsewhere as explained above. Also, information for each project that is needed in Sections E-L does not go here, but is placed instead as noted below.)
- Section 4. Developmental Projects
- Section 5. Shared Resources
- Section 6. Training and Career Development Program
- Research Plan Section E. Human Resources Address Human Subjects Research, as it is relevant to each part of the proposed center. You may subdivide by projects and cores if that is logical to provide clarity, or you may unify if the same information applies uniformly. No page limits apply to this section.
- Research Plan Section F. Vertebrate Animals Address Vertebrate Animal Research, as it is relevant to each part of the proposed center. You may subdivide by projects and cores if that is logical to provide clarity, or you may unify if the same information applies uniformly. No page limits apply to this section.
- Research Plan Section G. Select Agent Research
- Research Plan Section H Literature Cited. No page limits apply. Organize this as you see fit.
- Research Plan Section I. Multiple PI/PD Leadership Plan
- Research Plan Section J. Consortium/Contractual Arrangements
- Research Plan Section K. Resource Sharing Plans Address Data Sharing, Model Organisms, Genome Wide Association Studies
- Research Plan Section L. Consultants Place here any letters from individuals confirming their roles in any projects and any charges for consulting services.
Q: Should existing Advisory Board Members be named in a competitive renewal?
A: Yes, Advisory Board members who already sit on a CECCR l Board can be named in the application, prospective ones cannot.
January 14, 2008
Q: When should applicants name specific individuals for the Advisory Boards for P50's and when should they simply describe the functions of those advisors without giving individual's names?
A: If an Advisory Board has not met and will not be providing advice in advance of the application, then the application should describe functions and not provide any names. If an Advisory Board has met and provided input to the applicants on their program, then the names of the board members should be included in the application.
Q: Do all sections (including sample Developmental Projects) need to stick to the 81-character limit?
A: It is assumed that the question refers to the character limitation on title length. It would be best if the titles of all sections adhere to this limit, as information entered in our data systems used in meeting administration are limited in the number of characters that they can accept. If a longer title is used then on any forms generated from the database for purposes of the review meeting, the title will be truncated.
Q: In our application, we'll present a quantitative chart of publications, grants, and seminars. We'd like to include lists of citations backing up these data in the appendix. It's not clear in the NOT-OD-07-018 guideline if these are allowable, but we thought reviewers would want the chance to see where these numbers are derived. What's the ruling?
A: The items which are mentioned in this question would not constitute items which are generally allowed as appendix material. Listing this information in an appendix could be seen as an attempt to circumvent page limitations. The RFA specifies “NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. For details on what items are generally allowed as Appendix materials, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html”. Placement of the information in appropriate sections of the application is possible. For instance, citations of published works can be placed in the Literature Cited section without page limitation. Funding history can be listed within the individual biosketches of key personnel. It is also possible to create a table to summarize information and to include the table within the research plan. Font sizes in tables must be legible but are not held to the same requirements as “body text”.
January 2, 2008
Q: In the CECCR II RFA Q & A section, there is reference to a 40-page limit. Can you tell me to which section of the RFA this page limit applies? For Sections 1 through 6 I get a 38 page total. I am assuming Section 3 -- the 22 pgs per research project -- is not included in these totals. Thanks in advance.
A: You are correct. The 40 page limit refers to sections 1-6 and does not include the 22 pages allocated for each research project. The extra two pages for sections 1-6 allow you some discretion in realigning the internal page limits if necessary.
Q: Regarding page limitations: For the overall CECCR description, can we exceed the suggested page limit of 10? The individual R01 projects have a suggested page limit of 22; however, can we use up to the total 25 pages if needed per regular R01s? For the development projects, we have six pages to use. However it also says that applicants should supply a short description (2 pages maximum per project) of up to two eligible projects as examples. Are you asking then in these two pages for a summary of these projects? Or, are these individual development projects given six pages to discuss what they propose to do?
A: We are being cautioned to keep all page lengths well within suggested allowances for the proposals. That would mean keeping your overall CECCR description limited to 10 pages and the individual research projects at 22 pages apiece. The Division of Extramural Activities (DEA) likes to distinguish the research projects from true R01's -- they are "like R01's but not the same thing" -- which is why the limit is capped at 22 pages instead of 25. Some of the rationale is that much of the justification for each R01 will already be presented in the description of the overall CECCR.
Likewise, you've got two pages per each developmental project you'd like to describe, but that will have to be embedded within the overall 6 page limit for describing your approach to the pilots.
Q: Can there be more cores than R01 projects? The typical program project usually does not allow this. Also, each core has 10 pages to describe their roles, correct?
A: Regarding cores, yes you can have more cores than research projects. You will already have an administrative core (that's mandatory). A center could easily identify another 2-4 specialty cores, which would exceed the number of projects. In any case, all cores will have to be described within the total 10 pages allowed for the entire section (unlike the research projects, which get individual caps).
Q: Each full research project requires a face page, project summary and key personnel pages. Are those pages in addition to the 22 page limit or do they have to be part of the 22 pages?
A: We are being cautioned to keep all page lengths well within suggested allowances for the proposals; therefore, the 22 page limit is all inclusive.
December 18, 2007
Q: In the section on the RFA that refers to the new page limits, it seems that the page numbers allocated for each section do not add up to the overall page limit of 40, am I missing something here?
A: No, you aren’t missing anything; the numbers deliberately do not add up to give you some discretion. The internal page limits are only suggestions and total 38, yet the overall total is 40 pages. The 40 page limit is a "hard cap", but you can realign some of the internal page limits if needed.
Q: Is it true that we should budget the money for the developmental projects as a line item in our Administrative Core or that we should have a separate budget for the developmental projects?
A: The developmental funds should not be apart of the Administrative Core; they should be a separate budget component. You should submit form pages 4 and 5 for the cumulative developmental funds request.
December 17, 2007
Q: Can individual projects start in succession in year 1, year 2 and year 3?
A: Yes. In fact, three projects in succession could demonstrate a strategic "building" of the science by taking knowledge learned from the first project and applying it as input into the second. Such an approach, if defended properly, could suggest a programmatic line of research. It could add further value to the P-50 Centers concept by showing how a concentration of intellectual resources could be brought to bear on the problem of accelerating advances in cancer communication.
Q: Can different cores be located in different institutions?
A: Yes, there is nothing to preclude CECCR applicants from proposing that different cores be housed in different institutions. In fact, it is conceivable that such an approach could provide compelling value if the companion institutions housed contributing expertise that could benefit the center as a whole.
The burden, no matter what configuration is proposed, will be on the applicant to demonstrate that the Center is “ready to collaborate” according to the readiness factors described by Dan Stokols in Friday’s pre-application conference. That is, the Center should demonstrate that it has the communication infrastructure in place to allow non-proximally located colleagues to take full advantage of core resources. A governance structure should be in place that will encourage use of the core resources by all members of the Center, regardless of location. The PI and other leaders in the Center should be inclusive in their orientation. The application should assure reviewers that the critical mass needed to advance the science through a P-50 “Centers Grant” will be possible through a virtual environment as easily or better than it would be as a co-located, single campus.
Q: Could you clarify if the application should be submitted with 1.) At least one R01 with clinical relevance, with an instruction to the review panel that the rest of the proposal need not be judged against the criterion of clinical relevance, or 2.) A single R01 with clinical relevance and an expectation for the review panel that the entire proposal would be evaluated for its overall clinical relevance?
A: We have a requirement that at least one of the R01-type proposals be clinically relevant. Program directors can discuss with applicants whether the candidate R01-type project fits a minimum threshold for clinical relevance, but it will be up to reviewers to decide scientific merit, real clinical impact, etc. of the individually identified project.
Separate from the individual project, reviewers will look at the overall integrity of the Center. Here, the same sorts of criteria will apply as before. The Center should appear to be thematic and well-integrated. The one clinically relevant project should not appear to stick out like an afterthought, but should be oriented toward helping the Center build its own thematic knowledge base.
December 14, 2007
Abbreviated Q&A from webcast
Q: I have been approached by 3 groups that are likely to submit CECCR II applications. I am wondering about NCI's policy on being a part of multiple (competing) applications.
A: We are concerned that reviewers would knock off points if they saw co-investigators named from different institutions. The most appropriate thing to do might be to offer inclusion in only one proposal -- perhaps the proposal that gives you a more pivotal role. You could offer to re-evaluate your role on a competing proposal *after* the review has been completed and you know which Centers will be funded. We know, for example, that CECCR PI's served on each others' advisory committees once the projects stood up last time.
Q: I were to submit an unscored R01 as part of the application for a CECCR II, could I also submit it as a stand alone R01 application?
A: We think it would be a mistake to draw reviewers' attention to a failed R01 application, when crafting material for the CECCR's illustrative research project (R01-like project).
What you could do is draw many of the ideas and methodologies from the reviewed application, revise and adapt those in light of CECCR themes, then fold the study into the thematic emphasis of your CECCR application as an individual R01-like project. We can sort out overlap if both applications get funded later.
December 7, 2007
Q: Do you have a sense of a range in number of proposals that you may receive?
A: It is hard to say right now, but we’re expecting somewhere around 20-30 proposals to come in. It’ll be a competitive field, particularly given the emphasis on clinical care applications this time around.
Q: How important is it for the PI to be well-established in the precise field of cancer communication research?
A: This is a communication RFA so reviewers will be looking for the ability of the team to strengthen cancer communication science for the purpose of reducing cancer burden. Having said that, please recognize that patient-centered communication has been identified as a priority for the institute, as has the value of interdisciplinary work. If a team can show that its combined experience will contribute substantively to the field of cancer communication science, then a specific background in cancer communication is not that critical. In fact, cancer communication and informatics are by definition interdisciplinary fields with leaders drawn from general medicine, oncology, psychology, communication, computer science, health systems engineering, medical anthropology, public health, and other relevant disciplines.
Q: If our unifying theme were "ethics-oriented", would the study section and Council be more likely to view such a theme as "innovative" or unrelated to the priorities of the Program?
A: For CECCR II, the Behavioral Research Program is looking to accelerate progress against cancer through strategic investments in cancer communication and informatics. That means we need to be on a clear path toward population health. Ethics as an innovative theme would not be enough, in my opinion, to become its own objective.
Still, I could see an "ethics core" as a defining attribute of a proposal. The core could become an integral part of projects designed to improve system-patient communication, to encourage clinical trials accrual, etc. In other words, one could argue that ambiguous perceptions about ethical issues are driving patients away from full participation in their health care and that the team will create a Center to improve participation by addressing ethics issues as well as other motivational issues head-on.
In any case, the proposed science must be shown to be "material", in the sense that it will logically lead to marked reductions in pain and suffering from cancer. Some more proximal goals en route to that objective might be to follow the Institute of Medicine’s "Crossing the Quality Chasm" recommendations in making care: (a) safe, (b) effective, (c) patient-centered, (d) timely, (e) efficient, and (f) equitable.
Q: If we propose to do something that overlaps with the work of some of the intramural people at NCI, will that be considered a strength or a poor use of scarce resources?
A: Leveraging resources would be considered a plus; duplicating efforts would be considered a negative. You’ll notice that there is verbiage in this version of the CECCR regarding a requirement to “harmonize data elements” in line with investments in NCI’s cancer biomedical grid (caBIG). If you could use some of the same questions as those used by NCI-funded surveys, then show how your research has added to the evidence base by extending the Web of knowledge in communication, it would be valuable.
Q: How serious is NCI about soliciting new grants?
A: Very serious! Our Board of Scientific Advisors was clear in its insistence that this opportunity be considered a fair and open competition. Notice also, that the shift to clinically relevant applications will create a new – and in many respects level – playing field for all comers.
December 4, 2007
Q: Is there an expectation that the PIs for CECCR II centers should themselves be cancer communications researchers, or would someone like a basic scientist directing a multi-disciplinary cancer center, be viewed as qualified to lead such centers?
A: Our primary concern is that each CECCR advance the science of cancer communication and demonstrate this by research productivity that has an impact on reducing the cancer burden for patients and health consumers. We are serious about encouraging transdisciplinarity and our Division has funded other Centers of Excellence which contain basic scientists as pivotal researchers in tobacco and health disparities research.
The PI of a CECCR should have a perspective that goes well beyond basic science and includes both experience and knowledge about translating "bench to bedside" and beyond the bedside to general populations through evidence-based communication principles. It will of course be necessary to demonstrate that experience to the reviewers. One of the elements that will be closely scrutinized is the team that has been put together, not just for the individual research projects or cores, but for the Center as a whole, and the leadership of that Center is crucial. The leader of any Center will also be instrumental in encouraging collaboration and interaction with the other Centers and should have experience in working beyond the boundaries of any one institution.
November 20, 2007
Q: Is it really necessary to send a letter of intent and what happens if I don’t?
A: The letter of intent is very useful for us in terms of planning for numbers of reviewers and anticipating other needs. However, it is possible to submit an application without having submitted a letter of intent.
Q: I know that NIH now makes it possible for multiple PI’s to share a grant. Does this Announcement do that?
A: We are limiting the CECCR to a single PI for leadership. There may certainly be a cast of other very important players in the management scheme for the Center, but there should be one point of accountability for participating with NCI.
Q: There are now 4 Centers of Excellence in Cancer Communication funded by NCI. Are the incumbents given an advantage over new applicants?
A: We are extremely proud of the fine work produced by the Centers. Since they were funded, the science of cancer communication has progressed and the present announcement reflects this as well as an emphasis recommended by our Board of Scientific Advisors. Therefore, the applications from new researchers will be given the same consideration as those from the incumbents.
Q: Do the PI and senior investigators have to have degrees in communication?
A: We emphasize throughout the announcement the importance of interdisciplinary research. We hope, therefore, that the applicants will represent a range of disciplines and backgrounds for consideration.
Q: Are the examples of research given in the announcement either recommendations or suggestions?
A: They are neither. Because clinical application is a new emphasis, we wanted to give concrete examples of the type of research that researchers might be doing or want to do.
Q: There are suggested page numbers. How firm are these suggestions?
A: The limit of 40 pages is not a suggestion. However, any individual section can vary from the suggestion, so long as the total is 40 pages. Fewer pages are acceptable.
Q: How many Developmental Projects are required?
A: There is no required number; we anticipate that new projects may arise during the course of the Center’s existence, therefore we ask for submission of two possible projects.
Q: Can one of the R01s be focused on a physician training intervention (or must all of them have a strong patient focus)?
A: For the R01’s, the emphasis should be on positive outcomes for patients. It is conceivable that physician training, systemic restructuring of office practice, informatics support configuration, or other interventions could be hypothesized to lead to improved patient outcomes. However, that rationale should be clear in the proposal.
Q: Would an application from outside the USA be favorably received?
A: Nothing prohibits foreign PI’s, but there will be an added burden of proof. Basically, they will need to convince the reviewers that: (a) the work they’re going to be doing can really only be done in their country and (b) produce the kind of new evidence that could be translated pretty immediately into practice within the U.S. for the benefit of its own citizens.
They should also recognize that participation in two grant meetings a year along with monthly PI telephone calls will be mandatory. They’ll need to set aside the budget to cover those expenses.
Note: Please check regularly; questions from potential applicants will be posted as received. |
