Acute to Chronic Pain Signatures (A2CPS) Frequently Asked Questions (FAQs)

We appreciate your interest in the NIH Common Fund Acute to Chronic Pain Signatures (A2CPS) funding opportunities. The NIH hosted a pre-application interactive Q&A webinar (NOT-RM-18-021) on September 6, 2018 for the five program FOAs:

RFA-RM-18-031  

RFA-RM-18-032

RFA-RM-18-033

RFA-RM-18-034

RFA-RM-18-035

The NIH also hosted a pre-application interactive Q&A webinar on September 19, 2019 for RFA-RM-19-013 and also issued NOTICE RM-20-001.

In addition, this Frequently Asked Questions page is also updated to reflect questions received during each webinar:

General Questions

1. What is the NIH Common Fund?

2. Who should I contact if I need assistance with something that isn’t listed here?

3. Will the applicant webinars be posted online afterward?

4. Are multi-PI applications allowed?

6. Can NIH intramural investigators apply to any of the funding announcements?

7. What are “U” grants and how are they different from R01s?

8. Can I be a PI on an application for one FOA and also be a PI or multi-PI on an application submitted to another FOA?

9. What are the plans for data and resource sharing for this program?

10. Will the applications submitted to this FOA be reviewed in one study section?

11. Can NIH provide additional guidance on including milestones in the application?

12. What are some examples of quantitative milestones?

13. What must my application contain to be considered responsive?

14. How did the NIH estimate the projected cohort size and number of biomarkers?

15. May applicants consider other assumptions than the assumptions used by NIH in the initial power analysis?

16. How will biomarkers be selected?

17. Can NIH provide references for the transition rate used in the power analysis?

18. Are clinical trials allowed?

19. Who should I include in the study population?

20. What are some examples of candidate biomarkers that this study might include?

21. Which patient reported outcomes and performance measures should I choose and how do I measure?

22. What must my application have in order to be responsive to one of these RFAs?

23. Could I propose to include more than one type of surgery or musculoskeletal pain cohort in my study?

Questions Generated from the Applicant Informational Webinar:

A2CPS General Application Questions (for RFA specific questions see lower on the page.)

Abbreviations used below:

MCC: Multisite Clinical Centers

CCC: Clinical Coordination Center

DIRC: Data Integration and Resource Center

ODGC: Omics Data Generation Centers

24. Can applicants apply to more than one RFA as a PI or as a component of a project?Can applicants submit to one or more of these RFAs and also submit investigator-initiated or other types of NIH applications?

25. Do you have some idea how many awards you are making for each RFA?

26. Is a letter of intent required?

27. Do applicants to these RFAs need to fill our human subjects sections and biohazard sections?

28. For the budget, is the dollar amount listed on the FOA direct only, or direct plus indirect?

29. How was the budget determined?

30. In terms of the 10+ proposed biomarkers, how specific do we need to be? For example, should we propose a single gene, a single measure from a single brain region, etc.?

31. Would imaging quality assessment happen at the data collection site?

32. Who will coordinate data quality for brain imaging?

MCC Specific Questions:

33.The MCC FOA suggest that 50% of subjects should be enrolled and complete 6 months by 1 year. This means the first 6 months would need 50% enrollment. How tight is that schedule and can it be modified?

34. How would you approach realistic rates of 15% transition for some pain conditions?

35. Will a single grant with multiple centers will be funded or will individual applications be brought together to work on one surgical cohort?

36. Would NIH consider revising their sample size of 1800 subjects with a single injury type in 2 years?

37. If our cohort is smaller than 1800, then do we develop collaborations for the submission to achieve a full 1800 patient cohort before submitting, or can this happen during the planning year?

38. How do you eliminate previous drug dependence and similar confounds?

39. For the MCC, are the timepoints for data collection fixed?

40. Can we argue that more time points are necessary?

41. How similar should the types of surgery or pain events be?

42. For the MCC, there may be a tradeoff between homogeneity of the cohort and rapidity of enrollment. Which factor should be given greater weight/importance?

43. Since an MCC will be multisite, do the subcontracts need to be finalized/executed at the time of submission or can these be finalized during the planning year?

44. For the MCC, can sites decide to collect additional measures or biospecimens for questions of interest that are outside of the consortium?

45. Do all participants need to undergo brain imaging at each timepoint or can judicious selections be made for subsets of participants that will be imaged?

46. Can the brain imaging be done at multiple different sites under each MCC?

47. Since the MCC is only doing data collection, should the grant submission include planned analyses?

48. Can and how do pediatric studies fit into these funding announcements and opportunities?

50. Would proposing a clinical trial detract from the responsiveness to the MCC RFA?

51. What type of fractures and what type of thoracotomy were considered as possible acute trauma?

52. Must all the peri-operative subjects come from the MCC or can the MCC also recruit from other sites?

53. For peri-surgical pain data collection FOA, it is likely that data collection will occur at multiple sites. Do you see having one primary site & the lead site writing the proposal?Or will the proposal come from multiple PIs with each site PI being multi-PI?

54. Is breast cancer surgery an acceptable pain condition?

55. Are musculoskeletal trauma patients expected to be non-operatively managed?

56. For the musculoskeletal pain MCC, how close in time to the injury must the time 0 assessment need to be in order to be responsive to the RFA?

57. May I submit an application that proposes an alternative approach?

58. Were any final decisions about the project made at the recent Kickoff meeting?

59. Why are no foreign sites allowed?

60. Is there an expectation that all patients will undergo brain imaging, both preop and at all post op time points??

61. I am confused about the budget. The RFA has dollars from Common Fund, but the next line says budget is more open, which is true?

62. Should the application include experts in the analysis of biomarker data - e.g., omic data, or are analyses to be done by investigators already funded, outside the MCC?

63. How do we propose study endpoints if the NIH is choosing them?

64. Can we include international scientists as part of the team but not part of data collection?

65. Are there any examples of funded grants we can refer to?

66. Can the MCC propose to get patients from multiple different hospitals?

67. How do we develop a budget if we don’t know the endpoints to be chosen?

68. Is the idea that there will be one protocol that is followed by the two MCCs as much as possible? If the TKA protocol has been established, will the second MCC follow that as much as possible?

69. Should there be prior evidence of collaboration between sites feeding the MCC?

70. Is it desirable to have geographical/population diversity among sites feeding to the MCC?

71. When will the TKA protocol be finalized? Can it be shared with applicants?

72. Are you looking for new diagnostics for transitional makers or are these already established? Are we incorporating these?

73. What is the total dollars for the MCC?

74.How many awardees are you anticipating?

75. Can we continue to communicate with program coordinators once this webinar ends?

DIRC-Specific Questions:

76. Will the DIRC extract materials from samples?

77. Doesn’t the proposal for the DIRC depend on what biomarkers are selected? How does one put together a submission for the DIRC without knowing what measures are selected?

ODGC-Specific Questions:

78. Is the microbiome included among the biomarkers?

79. Can our application to the ODGC RFA include genomics?

80. Will sample handling be performed by the ODGCs individually, or will one group be responsible for handling/tracking all samples?

81. Is it possible to outsource multi-omics assays and analysis (i.e. pay for other companies to perform the assays and analysis)?

82. For the variant genotyping, should DNA isolation be included in the ODGC budgets?

This page last reviewed on October 18, 2019