Clinical Research Network Feasibility Awards (CRNFA)
Questions and Answers

1. Should our proposal be prepared in the traditional NIH format (e.g., Specific Aims, Background & Significance, Preliminary Studies, Methods & Design, Human Subjects, etc.) or in a contract format (e.g., specific deliverables by specific dates?
   
   A1: There are no format requirements; however there is a 10-page limit. Please also provide a cover page (see Additional Proposal Instructions: Cover Page Template)

2. Can contract funds be expended for pilot and feasibility studies offered to clinician-investigator members of our PBRN (i.e., NYU RING)
   
   A2: Yes, through either consultant or sub-contract agreements.

3. Will the Human Subjects section of the proposal be included in the 10 page limit of the final proposal?
   
   A3: Yes. It is understood that you will follow all Human Subjects requirements in order to undertake a study involving human subjects.

4. Are NIH biosketches and other support pages expected? If yes, should these be included as an appendix?
   
   A4: You may include biosketches and other information in the Appendix.

5. Does the $100,000 include indirects?
   
   A5: Yes.

6. Does this require sign off from our institution?
   
   A6: Yes, the PI of the CTSA must submit a letter of support. Each CTSA can submit only one proposal.

7. Are you wanting a full technical proposal (attached is our template) if yes, which sections are included in the 10 pages?
   
   A7: There are no format requirements; however there is a 10-page limit. Please also provide a cover page (see Additional Proposal Instructions: Cover Page Template).

8. Is the expectation to develop both a plan of collaboration and a research project? If so, will a mixed method study involving network clinician behavior change be acceptable?
   
   A8: The goal of these awards is to establish collaborations between CTSAs and existing Government funded research networks or clinical practice networks, which can result in mutual benefit. The study you describe sounds appropriate provided it is within one of the following research areas: Translational Science Dissemination Research, Cost-Benefit/Cost-Effectiveness Research, or Community Engagement Research.

9. Should biosketches be included and if so, do you only need biosketches for the PI's or do you need then for key personnel and consultants as well?
   
   A9: You may include biosketches and other information in the Appendix.

10. Does there need to be a letter of commitment from each participating institute?
    
    A10: Yes.

11. In addition to letters from the PI's do we need letters from potential consultants?
    
    A11: Not necessary.

12. What is the preferred template/length of the three reports (i.e. quarterly, semi-annual, and final)?
    
    A12: The progress reports will be brief and will describe achievements, plans, challenges and other information as requested.

13. What is the preferred indirect rate?
    
    A13: Whatever your institute provides.

14. Will the total award of $100,000 include both direct and indirect costs?
    
    A14: Yes.

15. Will a narrative budget be required to accompany the included template?
    
    A15: No.

16. What are the formatting requirements for the narrative (e.g., font, size, margin)?
    
    A16: Any font no smaller than 10; margins (top, bottom, and right, left) no smaller than ½ inch. Please also provide a cover page (see Additional Proposal Instructions: Cover Page Template).

17. Our group appreciates additional information regarding the expected deliverables of the contract. The Statement of Work suggests that the development, monitoring, and tracking of activities around the new collaboration are the primary endpoints. In the Instructions to Applicants, under "The technical proposal must accomplish the following:" does "1. Identify the area of research focus and describe the research project" - refer to the statement of work noted above as the research focus and project rather than give an expectation of executing a hypothesis-driven scientific experiment around which the collaboration will take place using the CRNFA funds?
    
    A17: No. We want you to identify the research area (Translational Science Dissemination; Cost-Benefit/Cost-Effectiveness; Community Engagement) and describe how the collaboration between the CTSA and network will be sustainable.

18. Please provide preferred metrics for evidence of sustainability in the context of the statement of work.
    
    A18: We are interested in your ideas about this.

19. Is the $100,000 maximum award intended to be all direct costs, or is this intended to be a total of directs and indirects?
    
    A19: Total of direct and indirect costs.

20. Will there be an opportunity for the awardees to interact and discuss their aims, methods, and findings? Should our budget include travel costs for such a meeting?
    
    A20: There are no plans for a meeting at this time.

21. . In the second item of the Statement of Work, is the intent of this contract to develop the approach to "study and analyze the components, functions, aims, and outcomes of the collaboration," or to actually complete such a study?
    
    A21: The intent is primarily to develop the approach to the collaboration rather than its completion. We are also interested in its potential for sustainability.

22. Is the intent of this RFP to document existing CTSA-PBRN collaborations, or to create such a collaboration, or both?
    
    A22: The intent is to create a new collaboration.

23. We are planning a project by two well respected organizations with established community health centers in two different states with the goal of learning new knowledge that can be replicated in many underserved communities. Does this collaboration meet the requirements of the RFR?
    
    A23: The focus of this award is on new collaborations between CTSAs and existing networks. Investigators are eligible to apply who can demonstrate and provide synergy with ongoing Government funded clinical research networks and clinical practice networks; e.g., Agency for Health Research Quality (AHRQ), Centers for Disease Control and Prevention (CDC), Health Resources and Services Administration (HRSA), NIH, etc. Proposals must focus on one of the following 3 areas: Translational Science Dissemination Research, Cost-Benefit/Cost-Effectiveness Research, and Community Engagement Research.

24. Are there any restrictions on items or services that may be included in the budget? Will a guidance document for preparation of the budget be forthcoming?
    
    A24: No restrictions. No guidance document.

25. Please confirm that our proposed partnership, between a CTSA and FQHCs, is responsive to the CRNFA RFP.
    
    A25: Yes, if the FQHC participates in clinical studies. For a more detailed explanation of a clinical research network, read the definition of a Clinical Research Network using Adobe Acrobat. Please elaborate on this in your proposal.

26. Is the funding specification inclusive or exclusive of indirects, and is the indirect rate that standard NIH rate negotiated by the relevant institution(s)?
    
    A26: The funding is inclusive of indirects. The indirect rate is up to your institution.

27. RE direct costs - do we use our federally negotiated rate, or does a different rate apply?
    
    A27: Use whatever rate your institution allows.

28. RE structure of the proposal - the RFP does not provide a structure or outline? Is there a recommended structure/format?
    
    A28: There are no format requirements; however there is a 10-page limit. Please also provide a cover page (see Additional Proposal Instructions: Cover Page Template).

29. Is there any problem with having multiple (i.e., two) PIs? The two of us represent different parts of campus and different programs; our intention is to both serve as project PIs.
    
    A29: No problem with multiple PIs.

30. Is the $100,000 maximum per award total or direct costs?
    
    A30: Total costs.

31. What is the nature of the limitation that "an institution can only submit, or be part of, a single application…" on page 1 of the RFA? For a single institution's application, can individuals from other CTSA institutions serve as advisors, consultants, etc. and receive reimbursement in the form of honoraria, travel expenses, etc.?
    
    A31: Each CTSA can submit only one proposal. Yes, people from other CTSA institutions can serve as advisors, consultants, etc. and receive reimbursement, as long as this is factored into the total cost budget.

32. Must the Research Network targeted for collaboration with the National CTSA Network be included on the Network for Clinical Research Website, if it is explicitly listed on the RFA?
    
    A32: No.

33. If the research network targeted for collaboration is a government-funded organization, which clinical investigator should be identified as the link to the network? The federal project officer? Program Director? Funded Investigator who chairs the research consortium? Others?
    
    A33: Not the federal project officer; someone at the network who is willing to take the lead in the collaboration.

34. Is there a definition of "synergy" as something that must be forthcoming by interaction with another governmental agency?
    
    A34: Webster's definition - "a mutually advantageous conjunction or compatibility of distinct business participants or elements (as resources or efforts)" is an appropriate definition. The intent is for existing CTSA investigators and existing networks to join forces to create that synergy.

35. We see multiple benefits of collaboration between the translational researchers at the University of Utah CTSA and the clinical investigators participating in Utah RCC for the HFCRN. We would like to inquire whether from the viewpoint of Westat the aims of our collaboration are within the scope of the intent of the CRNFA RFP, and whether there are aspects of the collaboration that should be expanded.
    
    A35: Based on the information provided in your Letter of Intent, the collaboration appears to be within the scope of the intent of the RFP.

36. As outlined in this letter of intent, our focus as part of CRNFA RFP would be to establish collaboration between the CTSA and three Utah based medical centers that comprise the Utah Regional Care Center for the HFCRN, and to be prepared, at the end of the one-year funding period, to expand the tissue collection and analysis to the entire HFCRN (Baylor, Duke, Harvard, Mayo, Minnesota, Utah, Vermont, Morehouse). We would like to inquire whether this timeline is acceptable to Westat. An alternative approach would be to shorten the pilot studies at the three Utah based institutions and plan expansion of the project to the non-Utah based HFCRN within the context of the CRNFA RFP.
    
    A36: This appears to be an acceptable timeline, as we are interested in evidence of potential for sustainability.

37. We are wondering whether an investigator who is not a PI or a co-PI of either the CTSA or the NIH Heart Failure Network can act as a co- PI of the CRNFA RFP-W08-001.
    
    A37: The PI must be an investigator at a CTSA affiliate or partner institution. It is not necessary that the PI get salary dollars from the CTSA.

38. Are we to propose a research project that links CRNs or is the goal of the award to build new/strengthen existing relationships without a specific research goal during the feasibility period?
    
    A38: There should be a research goal associated with the new collaboration between the CTSA and the network.

39. Will we be notified of an invitation to submit a full proposal (on November 3rd) or is anyone who submitted an LOI eligible to submit a full proposal by the deadline?
    
    A39: As long as your proposal meets the eligibility requirements you may submit a full proposal.

40. The PI on this project is faculty with a program that is primarily funded by the University of Wisconsin-Madison CTSA and for one of the five schools that are partners in the CTSA. Does this meet the requirements for PI eligibility? What kind of clarification might this item warrant in a full proposal?
    
    A40: Yes; please clearly state the affiliation. The PI can be an investigator at a CTSA affiliate or partner institution. It is not necessary that the PI get salary dollars from the CTSA.

41. Can the PI of our CTSA send a letter of support before the full proposal stage or should we wait to submit them together, if invited?
    
    A41: We would prefer that all materials be submitted together.

42. Finally, if invited, can the full proposal be sent as a PDF file to this email address?
    
    A42: Yes. Please also provide a cover page (see Additional Proposal Instructions: Cover Page Template).

43. Is the funding for these grants federal, partially federal, or non-federal?
    
    A43: This funding is a competitive subcontract award through Westat.

44. If a proposal is chosen for an award, what is the process for making slight changes within the budget (primarily to attribute for possible volatility of gas prices and travel)?
    
    A44: This is a subcontract, and changes can be made to the budget post-award, though not to the total budget.

45. PI eligibility definition.
    
    A45: The PI must be an investigator at a CTSA affiliate or partner institution. It is not necessary that the PI get salary dollars from the CTSA.

46. The RFP states that the collaboration must be between a CTSA and another entity - such as a practice based research network (PBRN)- that currently has ongoing federal funding. In our situation, while we have a CTSA, the collaborating PBRN - while originally funded by AHRQ - currently does not have ongoing federal funding. Would we qualify for consideration even though our PBRN currently is not funded?
    
    A46: Yes.