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Science of Behavior Change

Frequently Asked Questions for Science of Behavior Change FOAs

We appreciate your interest in the Science of Behavior Change funding opportunities and hope that you and your team will choose to submit an application. In order to maximize your chances of success, we would like to provide some guidance that may be helpful as you put the finishing touches on your application:

1. Your application should clearly state the targets (mechanisms or processes) on which it will focus, and the health behaviors that changes in those target processes are hypothesized to cause. Stated another way, your application should describe hypothesized causal chains, starting from your chosen manipulations of a target to resulting changes in health behaviors. We say “describe causal chains” because it is likely that there will be separate causal chains for each chosen target-health behavior relationship.

2. In response to the Letters of Intent received and other questions from potential applicants, we have developed additional FAQs which have been added below. Topics that seem to be particularly confusing are what constitutes medical regimen adherence and how to make the case for the relevance to clinical outcomes or conditions in the application. Please review these FAQs to be sure that your application is consistent with the information provided here.

3. For clarification of these or other issues, we encourage you to talk with one or more of the scientific contacts listed in the RFA to which you are applying.

1. What is the Common Fund?

2. What is the Science of Behavior Change Program?

3. What is the experimental approach?

4. What scientific expertise is required for the experimental medicine approach to behavior change?

5. What are putative intervention targets?

6. Why do these announcements have a specific focus on adherence to medical regimens?

7. What is meant by medical regimen adherence?

8. Who are appropriate subjects, and what is an appropriate setting, for this research? Does the work on medical regimen adherence need to be conducted in individuals for whom specific medical regimens have been prescribed or recommended?

9. What are cooperative agreements?

10. What is the SOBC Research Network Steering Committee?

11. How are Program Officers assigned for Common Fund programs?

12. Can applications from the same institution be submitted for a UH2/UH3 project and the U24 Resource and Coordinating Center?

13. Can an institution/research team submit more than one application to a one RFA or submit an application to more than one of these companion RFAs (i.e., one interpersonal and social processes project and one self-regulation project)?

FAQs Specific to the UH2/UH3 RFAs (RFA-RM-14-018RFA-RM-14-019RFA-RM-14-020)

14. The UH2/UH3 RFAs mention the need to focus on targets relevant to two (or more) health behaviors relevant to two (or more) clinical endpoints or conditions. How are these targets, behaviors and endpoints supposed to be related?

15. Can a project be funded as a UH2 for the 5-year award period?

16. Does adherence to medical regimens have to be included in my application?

17. What type of expertise is necessary for the UH2/UH3 investigator team?

18. Are studies of preclinical nonhuman primates responsive to these RFAs?

19. Can these projects support the conduct of a large scale clinical trial?

20. If clinical trials are not permitted, is this announcement just calling for basic science?

21. What sorts of experimental manipulation or intervention techniques are permitted for testing target engagement?

22. Can research teams span institutions?

23. Can an institution or research team submit more than one application to a given RFA (or submit one interpersonal processes project and one stress project)?

24. How will the transition from UH2 to UH3 be determined?

FAQs Specific to the U01 Resource and Coordinating Center (RCC) RFA (RFA-RM-14-017)

25. What is the role of the Resource and Coordinating Center (RCC) and how will it relate to the UH2/UH3 projects?

26. What type of expertise is necessary for the RCC investigator team?

Questions generated from the January 21, 2015 Webinar

27. Is integrated data analysis on existing data permissible for the UH2 phase?

28. Is the new biosketch format required?

29. What types of samples or populations are considered appropriate for UH2 phase (e.g., clinical, disease-specific, org general population)?

30. What constitutes medical regimen adherence? Would exercise count?

31. For the UH2, will we have to test the link between medical regimen adherence and, for example, self-regulation?

32. Is the funding cap for the UH3 phase of the project $1.25 million per year, or for the total UH3 phase?

33. Are senior investigators likely to be more successful give the collaborative nature of these projects? Is it expected that senior investigators will be the ones applying?

34. Can applications involve qualitative data collection as part of measuring putative targets? [Relevant to FAQ #27]

35. Does the Resources and Coordinating Center have a separate RFA or does each application need a coordinating center?

36. Do interventions need to be on an individual level or a community level?

37. Would it be better to have multiple PD/PI as well as multi-institutions apply?

38. How should applicants budget for the UH3 phase if the results of the UH2 phase are unknown? For example, how would specific budget lines be determine?

39. How many awards are expected to be made for each RFA?

40. Would probing the targets using pharmacological probes be acceptable?

41. For the budget caps, are the indirect cost associated with the subcontract sites part of the total cost, or are they separate from (in addition to) the total cost?

42. Please clarify what is meant by basic in the RFA where it notes that "both basic and clinical scientist" are required for the UH2/UH3 teams? Does basic here mean testing human blood and/or tissues, research in animals, or something else?

43. I’m still confused about how to study adherence in these applications. What are the expectations regarding how adherence is studied?

44. What outcomes are required for the UH2 phase?

45. I understand that applications must be relevant to at least two clinical outcomes or conditions, but where in the research plan should relevance to those outcomes be demonstrated?

46. Do I have to include the Team Science Justification and Organization requirement noted in Section IV.2 of the RFA? Does this take the place of the multiple PI application requirements?

FAQs Specific to the Science of Behavior Change Administrative Supplements (PA-16-344)

47. Who is eligible to apply for these administrative supplements?

48. I have a project supported by a CTSA KL2 grant. Can I apply for a supplement?

49. What are putative intervention targets?

50. Does the intervention need to be an already validated procedure?

51. Is it expected to use mediation analysis to analyze the data?

52. Should one use the Research Domain Criteria (RDoC) approach recommended by the National Institute of Mental Health?

53. Do we need to show not only that the treatment moves target, but also whether engaging the target impacts clinical endpoints? Also, will we need to measure the putative mechanism at more than one time point? Is that feasible in the time frame and budget?

54. Should the primary outcome be a behavior versus clinical outcomes, such as body composition?

55. Are Principal Investigators able to select broad clinical targets such as the gut microbiome?

56. What is meant by medical regimen adherence?

57. Are studies of preclinical nonhuman primates responsive to this PA?

58. What sorts of experimental manipulation or intervention techniques are permitted for testing target engagement?

59. How many awards are expected to be made for this PA?

60. Is the $2 million dollars of funding available as indicated in the FOA the total amount for all the awards, or for each award?

61. If there is approximately $2 million available and there will be 10–12 awards, would this imply budgets of approximately $150-$200K for most supplements?

62. Would probing the targets using pharmacological probes be acceptable?

63. Does this opportunity apply to provider behavior?

64. Is a grant project eligible if it is not currently part of the SOBC Research Network?

65. Are current SOBC Research Network awardees eligible to apply?

66. Is a subcontractor to an R01 award allowed to apply?

67. Can one Principal Investigator submit two applications for two different R01 parent awards?

68. Can a Principal Investigator apply for and receive this supplement award if he/she is also applying separately for a diversity supplement?

69. Are international consultants allowed on the budget?

70. I have a study supported by the Clinical and Translational Science Award (CTSA) pilot program at my institution. Can I apply for a supplement under this FOA?

71. Can this be a multiple Principal Investigator (PI) supplement with the original PI and a new PI together? Can the supplement include a Co-PI who was not included on the parent grant?

72. Is there a minimum percent effort that PIs need to include in the budget to demonstrate adequate time/commitment?

73. If an otherwise-eligible grant project already incorporates aspects of the experimental medicine approach, is it still eligible for this funding opportunity?

74. May I apply for support to recruit additional participants for an experimental medicine sub-study, so that I don’t compromise the parent study?

75. Can one apply for this supplement for a project that has not begun recruiting but will be recruiting by the time the supplement is awarded?

76. Can one request a delay in the supplement if awarded until a substantial number of participants have been enrolled?

77. Is there a limit to the amount of funding requested for an administrative supplement project in response to this program announcement?

78. My project will be in a no-cost extension by the time these are awarded. Can I still apply?

79. How will these applications be reviewed?

80. Are reviewers able to view the parent grant or do submissions need to include enough details about the parent grant and explain how this submission is synergistic or different?

82. How long should my application be?

83. What does the six-page research strategy need to include? Is there a list of required elements?

84. Is there a one-page specific aims in addition to the six pages?

85. Can I apply for multi-year funding for the supplement?

86. You’ve said that these are 1-year awards. What if the design requires retesting and a longer time frame to collect the data? Can the supplemental project use a no-cost extension?

87. If a parent study has more than 1 year remaining, can the supplement funds be used across the remaining years?

88. Does the supplemental project have to show change in a clinical endpoint?

89. When do you think I need to talk to my Program Official and one of the scientific contacts?

90. Who should I talk to if I have more questions?

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