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?
The NIH Common Fund, managed by the Office of Strategic Coordination in the Office of the Director, supports cross-cutting trans-NIH programs that require participation by multiple Institutes and Centers. Common Fund programs are intended to be transformative, catalytic, synergistic, cross-cutting, and unique. More information can be found at http://www.commonfund.nih.gov
2. What is the Science of Behavior Change Program?
The Science of Behavior Change (SOBC) is a Common Fund Program that began in 2009 with a focus on studying mechanisms of behavior change in the laboratory and the field. The overall goal of the SOBC Program is to implement a mechanisms-focused, experimental medicine approach to behavior change research and to develop the tools required to implement such an approach. These announcements are the first to be issued under the second 5-year period of the SOBC Program. More information about past and current SOBC Program activities can be found at http://www.commonfund.nih.gov/behaviorchange
3. What is the experimental approach?
The experimental medicine approach, as applied to behavior change research, involves identifying an intervention target, developing assays (i.e., measures) to permit verification of target engagement, engaging the target through experimentation or intervention, and testing the degree to which target engagement produces the desired behavior change.
4. What scientific expertise is required for the experimental medicine approach to behavior change?
Teams consisting of both basic and intervention scientists are needed to advance this agenda. Basic researchers in the behavioral sciences are needed to identify candidate measures of processes that are thought to be causally linked to health behaviors and conduct tests to verify that these processes can be manipulated. Intervention scientists are needed to conduct the theory testing and experimentation that constitutes Stage 0-1 research in the behavioral intervention development pipeline.
5. What are putative intervention targets?
For the purpose of these Requests for Applications (RFA) (RFA-RM-014-018
), putative intervention targets represent mechanisms or processes that are hypothesized to be measurable, malleable, and to play a causal role in producing behavior change. It has been hypothesized that self-regulatory functions, processes involved in stress reactivity and stress resilience, and a range of interpersonal and social processes play causal roles in motivating, initiating and maintaining behavior change, including adherence to medical regimens. If this is the case, then intervening to alter these processes could result in behavior change. The UH2/UH3 funding opportunities (RFA-RM-014-018
) call for applicants to identify intervention targets in these three broad domains that they believe can be manipulated and measured to test whether they indeed play such a causal role.
6. Why do these announcements have a specific focus on adherence to medical regimens?
Well-documented non-adherence to medical regimens serves as an exemplar of the challenges in initiating and sustaining healthful behavior change. Recognizing this challenge, NIH has determined that all projects must include a focus on adherence to medical regimens. It is important to underscore that a unifying principle of the SOBC Program is that common mechanisms underlie successful and unsuccessful behavior change across a range of behaviors and clinical conditions. Hence, aspects of self-regulation (for example) applicable to medical regimen adherence may be relevant to a number of other health behaviors. That principle can be formally tested in the proposed projects. Reference: Haynes, R.B., Ackloo, E., Sahota, N., McDonald, H.P., & Yao, X. (2008). Interventions for enhancing medication adherence.Cochrane Database of Systematic Reviews,
Issue 2. Art. No.: CD000011. DOI: 10.1002/14651858.CD000011.pub3. Retrieved from http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD000011.pub4/pdf
7. What is meant by medical regimen adherence?
For the purposes of these RFAs (RFA-RM-014-018
), medical regimen adherence includes, but is not limited to, the following: adherence to prescribed medications, adherence to prescribed screening and immunizations, adherence to behavioral regimens prescribed by a physician or health professional, including follow-up tests, dietary modifications, etc. See also FAQ #30
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?
Medical regimen adherence is one of the behavior change outcomes that must be examined and applicants must justify the selection of research participants for investigating the questions posed for any health behaviors of study. For the purposes of these RFAs (RFA-RM-014-018
) work may be conducted in experimental contexts or in clinical contexts, with subjects who do or do not have disease, disorders, or health conditions. Thus, subjects may be healthy individuals or those engaged in prevention or treatment protocols, in laboratory or field experiments, or in a clinical context, as long as the goals of the RFA are met. The ultimate goal for the UH2/UH3 projects will be to demonstrate short-term behavior change under controlled conditions. Regardless of whether the work is conducted in a specific disease context, a clinical population, or in non-clinical contexts, the outcomes of interest are health behaviors relevant to multiple clinical endpoints, not the specific clinical endpoints themselves. See also FAQ #29
9. What are cooperative agreements?
A cooperative agreement funding mechanism supports discrete, specified, circumscribed projects to be performed by investigators in an area representing their specific interest and competencies and is used when substantial NIH programmatic involvement is anticipated. In addition to a Program Officer from the administering Institute, each award will be assigned a Project Scientist from NIH who will participate with the Principal Investigators on a Steering Committee.
10. What is the SOBC Research Network Steering Committee?
The SOBC Research Network Steering Committee will be the main governing board of the SOBC Research Network, which will be comprised of all the funded UH2/UH3 projects (RFA-RM-014-018
) and the U24 Resource and Coordinating Center (RFA-RM-014-017
). Voting members of the Steering Committee include the Principal Investigators of the awards and the NIH Project Scientists assigned to each project. The Steering Committee will meet in person at a kick-off meeting before the end of calendar year 2015 and then annually thereafter in each award year. Key project collaborators and other NIH staff as appointed by the SOBC Working Group co-chairs can participate in the annual meetings. The Principal Investigator of the Resource and Coordinating Center will serve as chair of the Steering Committee for the first award year. Thereafter, the group will select its chair from among the members. Applications must include budgets to support the travel of Principal Investigators and key collaborators to these annual meetings. Please see the Cooperative Agreement Terms and Conditions of Award
section in the RFAs (RFA-RM-014-018
) for additional information.
11. How are Program Officers assigned for Common Fund programs?
Applications will be assigned to Program Officers from various Institutes and Centers that participate in the SOBC Program. After scientific review, the SOBC Working Group
will make funding recommendations to the Common Fund and applications will be reviewed by the administering Institute’s advisory board. The administering Institute will function as the award administrator; however, the awards will be funded by the Common Fund.
12. Can applications from the same institution be submitted for a UH2/UH3 project and the U24 Resource and Coordinating Center?
Yes, applications for more than one of the SOBC RFAs can be submitted from the same institution. However, awards for a UH2/UH3 project (RFA-RM-014-018
) and the Resource and Coordinating Center (RFA-RM-014-017
) will not be given to the same institution due to potential conflicts of interest. Applicants may consult with NIH staff to ensure that any potential conflicts of interest are eliminated prior to the award.
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)?
Yes, there is no prohibition on the number of applications an institution may submit, provided the applications are scientifically distinct.
FAQs Specific to the UH2/UH3 RFAs (RFA-RM-14-018, RFA-RM-14-019, RFA-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?
The limits on the two health behaviors and two clinical endpoints represent the lower bound for what applicants should propose. All of the targets selected should be relevant to both of the selected health behaviors. In addition, any health behavior studied should be relevant to at least two clinical endpoints. For example, a team may choose to focus on the health behaviors of smoking and adherence. Both are relevant to the clinical endpoints of cardiovascular disease and cancer. Adherence is also relevant to diabetes. A team might propose to examine two targets in the domain of self-regulation that are hypothesized to impact both smoking and adherence (e.g., an aspect of cognitive control and an aspect of emotion regulation). The team may also elect to focus on other targets in that domain that are relevant to other health behaviors. The SOBC Program, with input from experts in the field of behavior change, have proposed that targets in the three domains of self-regulation, stress reactivity and stress resilience, and interpersonal and social processes that are the focus of these three UH2/UH3 RFAs, are relevant to multiple health behaviors involved in multiple clinical endpoints, and thus relevant to the missions of several NIH Institutes and Centers. Applications with a narrow focus on one clinical endpoint would be inconsistent with the broad goal to develop tools for a unified science of behavior change that addresses multiple and often co-occurring clinical problems. Applicants must make the case for the relevance of the selected targets and health behaviors to clinical endpoints. However, applicants are not required to demonstrate change in clinical endpoints. The outcomes of interest in the later stages of these projects are changes in health behaviors. There is no requirement to measure clinical endpoints.
15. Can a project be funded as a UH2 for the 5-year award period?
No. UH2 awards provide three years of funding. The subsequent two years of UH3 funding depends upon completion of objectives and NIH administrative review at the end of the UH2. UH2 projects that do not meet the awardee-specified milestones by the end of the third award year, as determined by NIH administrative review, will not continue to receive support.
16. Does adherence to medical regimens have to be included in my application?
Yes. Applications without at least one component focused on adherence to medical regimens will be deemed unresponsive to these RFAs. For the purposes of these RFAs (RFA-RM-014-018
), medical regimen adherence includes, but is not limited to, the following: adherence to prescribed medications, adherence to prescribed screening and immunizations, adherence to behavioral regimens prescribed by a physician or health professional, including follow-up tests, dietary modifications, etc.
17. What type of expertise is necessary for the UH2/UH3 investigator team?
These projects require expertise from basic behavioral scientists working to understand the basic processes involved in either self-regulation, stress reactivity and stress resilience, or interpersonal and social processes relevant to health behaviors. It also requires individuals with expertise in mechanistically-informed behavioral intervention research. It is anticipated that teams will include individuals from a range of disciplines, some of whom may have not previously collaborated across the full basic to applied spectrum envisioned here. See also FAQ #37.
18. Are studies of preclinical nonhuman primates responsive to these RFAs?
No. These RFAs (RFA-RM-014-018
) will support early stage behavior change intervention activities in humans related to developing and testing specific experimental manipulations or controlled interventions that engage a specified behavioral or social target. These RFAs will not support assay development in animal models, although a team may include expertise in animal models relevant to behavior change.
19. Can these projects support the conduct of a large scale clinical trial?
No. These RFAs will not support the development of diffuse or multi-component interventions, or full scale clinical trials as defined by the NIH
(e.g., Phase III or IV, or Stage 2-4). Applications involving large-scale clinical trials will be deemed nonresponsive. These RFAs will support Stage 0 and Stage I work. As with all the stages of intervention development, Stage 1 research is an iterative, recursive process. Stage I involves the creation of a new intervention, or the modification, adaptation, or refinement of an existing intervention. Feasibility and pilot testing are also considered to be part of Stage I (“Stage 1B”). One goal of a Stage I project is to produce the essential materials and information to proceed to another stage of intervention development (e.g., Stage II or Stage III). Another essential goal is to obtain basic scientific knowledge of the behavioral, cognitive, social or biological mechanism of behavior change mechanisms of behavior change (Stage 0). This involves, like all the Stages of intervention development, testing the theory upon which an intervention is based. Small scale pilot Stage 1 clinical trials may be supported by this RFA. In addition, some of the work supported under these RFAs may be conducted within the context of an existing clinical trial. However, the primary goal of the UH2/UH3 is to conduct a range of studies to determine whether specific behavior change targets in the domains of self-regulation, stress reactivity and stress resilience, and interpersonal and social processes, can indeed be manipulated, whether measures exist (or can be developed) to demonstrate that this manipulation has occurred, and to establish whether manipulation of these targets leads to measureable change in two or more health behaviors under controlled conditions. Reference: Onken, L., Carroll, K., Shoham, V., Cuthbert, B., & Riddle, M. (2014). Re-envisioning clinical science: Unifying the discipline to improve the public health, Clinical Psychological Science, 2, 22-34.
20. If clinical trials are not permitted, is this announcement just calling for basic science?
No. To be precise, these announcements (RFA-RM-014-018
) are calling for an integration of approaches and principles from basic behavioral science and mechanistically informed behavioral intervention science. In the course of the proposed work, teams may conduct basic behavioral experiments, typical of those often conducted within the fields of social psychology, cognitive neuroscience or affective science, and may perform manipulations—either experiments, novel intervention approaches or new manipulations, or measurement activities within the context of ongoing intervention studies—to test mechanisms of action. Teams may conduct measurement development activities. They may develop novel or refine existing intervention (i.e., target manipulation) techniques.
21. What sorts of experimental manipulation or intervention techniques are permitted for testing target engagement?
There is no limit on approaches here. Applicants proposing specific techniques should make the case that the manipulation/intervention has potential to engage the target. However, note that these RFAs will not support the development of diffuse or multi-component interventions, or full scale clinical trials as defined by NIH (see above).
22. Can research teams span institutions?
Yes. Team members may span multiple institutions, and it is possible that the full range of expertise needed for a single proposal may not exist at one institution. Teams are expected to assemble the expertise across labs, disciplines, institutions needed to achieve the target validation aims proposed. Collaborative research teams must include basic and clinical science expertise as well as expertise in the relevant target areas (self-regulation, interpersonal and social processes, and stress reactivity and stress resilience) across multiple levels of analysis (e.g., neurobiological, psychological, behavioral, social), and expertise in behavior change research relevant to one or more health behaviors, including adherence to medical regimens. It is expected that the assay validation work conducted under these initiatives will require the combined expertise of both basic behavioral scientists and intervention scientists. The collaborative nature of the work will require that there are procedures in place to for regular communication, developing protocols and sharing results. An application could involve several labs working on common problems. See also FAQ #37.
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)?
There is no prohibition on the number of applications an institution may submit, provided the applications are scientifically distinct.
24. How will the transition from UH2 to UH3 be determined?
Teams must meet the objectives listed in the RFAs (RFA-RM-014-018
), according to procedures established after awards are made. Based on successful completion of objectives, program priorities, and availability of funds, decisions will be made by NIH regarding advancement to the UH3 phase.
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?
The RCC will facilitate communication and coordination among the UH2/UH3 projects. Applications should describe a strategy for how the RCC would fulfill its primary functions: establishing, maintaining, and disseminating a publicly available registry of validated assays and experimental methods for inducing and measuring specified behavior change targets; developing and disseminating technical guidelines and best practices for the validation of assays of behavior change targets; conducting systematic reviews of the behavior change literature, and specifically the medical adherence literature, to identify additional potential targets for future validation research; coordinate activities among the UH2/UH3 awardees, particularly those working on the same classes of targets (i.e., self-regulation); and organize the annual meetings and teleconferences of the Steering Committee, External Scientific Panel, and related subcommittees.
26. What type of expertise is necessary for the RCC investigator team?
The RCC team requires content, methods, and coordination expertise. The RCC is expected to have significant experience and knowledge in the following areas: •
- Conducting systematic reviews and meta-analyses of existing clinical trial reports and archived data sets, and using these sources to generate testable hypotheses concerning potential putative intervention targets, differential response of individuals to treatment, and estimates of intervention efficacy and effectiveness.
- All aspects of behavior change research and NIH-approved Good Clinical Practices (see http://www.nhlbi.nih.gov/research/funding/research-support/crg/managemen... for more information) as well as ethical issues related to clinical research.
- Facilitating cooperation between basic and clinical scientists and in behavioral intervention development.
- Helping to take research questions from hypothesis to implementation and the ability to document these processes.
- Study design and statistics, particularly with novel designs and methods that could enhance the efficiency of validation studies and behavioral trial designs.
- Creativity and innovation in solving technical and project challenges, as well as coordinating efforts among disparate research communities.
- The three target domains (self-regulation; stress reactivity and stress resilience; interpersonal and social processes) sufficient to participate as a member of the subcommittee for that target domain and ensure that products produced by target domain subcommittees will be suitable for the first three objectives of the RCC.
Questions generated from the January 21, 2015 Webinar
27. Is integrated data analysis on existing data permissible for the UH2 phase?
Integrated data analysis is one of many methodological approaches that can be proposed to achieve the objectives of the UH2 phase of the project. The applicant team should make the case for the appropriateness of the methodological approaches proposed to identify, engage, and verify hypothesized putative targets relevant to the target domain of the RFA.
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)?
No restrictions have been placed on the types of samples or populations considered appropriate to fulfill the objectives of the funding opportunity announcement. For the purposes of these RFAs (RFA-RM-014-018
) work may be conducted in experimental contexts or in clinical contexts, with subjects who do or do not have disease, disorders, or health conditions. Thus, subjects may be healthy individuals or those engaged in prevention or treatment protocols, in laboratory or field experiments, or in a clinical context, as long as the goals of the RFA are met. See FAQ #8 above. The ultimate goal for the UH2/UH3 projects will be to demonstrate short-term behavior change under controlled conditions and in response to target engagement. Regardless of whether the work isconducted in a specific disease context, a clinical population, or in non-clinical contexts, the outcomes of interest are health behaviors relevant to multiple clinical endpoints, not the specific clinical endpoints. The applicant team should justify the appropriateness of the sample or population to be used to fulfill the specific aims of the project and the overall objectives of the funding opportunity announcement.
30. What constitutes medical regimen adherence? Would exercise count?
For the purposes of these RFAs, medical regimen adherence includes, but is not limited to, the following: adherence to prescribed medications, adherence to prescribed or recommended screenings and immunizations, adherence to behavioral regimens recommended by a physician, dentist, or other health professional, including follow-up tests, dietary modifications, etc. See FAQ #7 above. In 2003, the World Health Organization defined medical regimen adherence as taking into account “the extent to which a person’s behavior—taking medication, following a diet, and/or executing lifestyle changes (including, for example, science based physical activity guidelines
), corresponds with agreed recommendations from a health care provider” (see page 3http://apps.who.int/iris/bitstream/10665/42682/1/9241545992.pdf
). The Centers for Disease Control and Prevention have developed health-related guidelines. Adherence to these guidelines may be one example of adherence to a medical regimen. Applicants are encouraged to consider whether the specificity of a guideline or lifestyle change is sufficient to test the engagement of a specific target, and then to test whether engagement of that target leads to specific behavior change.
31. For the UH2, will we have to test the link between medical regimen adherence and, for example, self-regulation?
No, a test of the link between medical regimen adherence and, for example, self-regulation, is not required during the UH2 phase of the project. However, such interrogation is an explicit requirement of the UH3 phase of the project. Specifically, during the UH3 phase, the applicant team is required to propose activities to test the degree to which engaging identified targets (e.g., putative targets within the self-regulation domain) produces a desirable change in medical regimen adherence and at least one other health behavior.
32. Is the funding cap for the UH3 phase of the project $1.25 million per year, or for the total UH3 phase?
As published in Section II Award Information of RFA-RM-014-018
, applicant budgets for the UH3 phase are limited to $1.25M in total costs in FY18 and $1.25M in total costs in FY19 (i.e., $1.25M per year).
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?
As specified in the RFAs, any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) is invited to work with his/her organization to develop an application for support. The RFAs call for teams of scientists to conduct target validation activities to develop the tools required to implement a mechanisms-focused, experimental medicine approach to behavior change research. Teams consisting of both basic and intervention scientists, regardless of academic rank, are needed to advance this agenda. Basic researchers in the behavioral sciences are needed to identify candidate measures of processes that are thought to be causally linked to health behaviors and conduct tests to verify that these processes can be manipulated. Intervention scientists are needed to conduct the theory testing and experimentation that constitutesStage 0-1 research in the behavioral intervention development pipeline. Our only expectation is that the teams that apply will have necessary skills, knowledge, and resources to complete the work proposed.
34. Can applications involve qualitative data collection as part of measuring putative targets? [Relevant to FAQ #27]
Yes. The applicant team should make the case for the appropriateness of the methodological approaches and the data sources (qualitative and/or quantitative) proposed for use to achieve the objectives of the RFAs.
35. Does the Resources and Coordinating Center have a separate RFA or does each application need a coordinating center?
Applications submitted in response to RFA-RM-014-018
are for assay development and target validation activities only. Applicants to those RFAs are not required to include a scientific or budget plan for a resource and coordinating center; to do so would be out of scope for RFA-RM-014-018
, RFA-RM-014-020. The NIH Science of Behavior Change Research Coordinating Center (RCC) (U24) announcement is a separate solicitation. The RCC awarded in response to RFA-RM-014-017 will work with and on behalf of all of the Target Validation Projects; individual projects will not require a coordinating center. Applicants to the UH2/UH3 RFAs are eligible to submit a separate application for a U24 RCC in response to RFA-RM-14-017. The technical assistance webinar for RFA-RM-14-017 is scheduled for February 5, 2015 at 1:30 p.m. EST. Please visit https://events-support.com/events/NIH_SOBC_Program_2
to register for the webinar.
36. Do interventions need to be on an individual level or a community level?
Much of the behavior change work the NIH seeks to promote with this initiative involves prevention, which often occurs outside of a clinical context. Although medication regimen adherence tends to take place in a clinical domain and often involves clinical interventions, prevention targets could certainly be engaged with manipulations or interventions conducted in communities, families, workplaces, schools, or other social contexts. In addition, for projects involving targets in the interpersonal and social processes domain (RFA-RM-014-018
), if the target(s) selected are at the community level, it is possible or likely that the experimental manipulation or intervention will be at the community level. Such projects could identify a specific target at the community level that the intervention/manipulation will engage. Particularly for RFA-RM-14-018, there is no requirement that an experimental manipulation or intervention be at the individual level.
37. Would it be better to have multiple PD/PI as well as multi-institutions apply?
Multiple Program Director(s)/Principal Investigator(s) (PD/PI) applications are eligible but not necessary. Visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide. The UH2/UH3 research teams should comprise members with the requisite skills, knowledge, and resources to carry out the proposed research and address the RFAs’ objectives (see FAQ #27 above, for a related answer). Members of the team need not be from the same laboratory, department, or institution. Each application must include a Team Science Justification and Organization attachment; for additional instructions on the scope of this requirement, visit Section IV.2 Application and Submission Information, Content and Form of Application Submission.
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?
To be considered responsive, application submitted to RFA-RM-014-018
require a scientific and budget plan for both UH2 and UH3 phase activities. The objective for the UH3 phase is to complete Step 4 of the target validation activities (i.e., to evaluate the validity of putative targets by integrating assays developed in the UH2 phase into controlled experiments or early stage interventional studies). The applicant team is expected to diligently propose a budget within the $1.25M in total costs limit per year in FY18 and in FY19 that will support plans for UH3 activities. However, given the iterative nature of the work required to fulfill the RFAs’ objectives, we anticipate the need to negotiate and refine UH3 milestones and activities based on UH2 milestone achievement and results. The transition from the UH2 to the UH3 phase is determined through an administrative review. Scientifically justified changes to the budget, reflected in revised budget justification documents as applicable, can be submitted for administrative review consideration. The flexibility of this cooperative agreement permits the use of multiple strategies to achieve the RFAs’ objectives, so consider this flexibility as you prepare your budget and budget justifications.
39. How many awards are expected to be made for each RFA?
The number of awards is subject to the availability of funds. The NIH Common Fund intends to commit $5.5 million in FY 2015 collectively across RFA-RM-14-018, RFA-RM-14-019, and RFA-RM-14-020 to fund a total of six awards, contingent upon receiving scientifically meritorious applications. It should be noted that this does not literally translate into 2 awards per each of the three RFAs. The NIH Common Fund intends to commit $4.5 million in FY2016 across the same three FOAs, and $5.0 million in each of FY2017, FY2018, and FY2019, contingent upon sufficient funding.
40. Would probing the targets using pharmacological probes be acceptable?
The RFAs do not restrict the types of experimental or interventional methods used to engage and verify the engagement of putative targets. If using a pharmacological probe will provide insights on whether you are engaging particular putative target(s), then make the case in your application.
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?
Yes, all costs are included in the total cost budget limitations for each RFA. For the UH2 phase, application budgets are limited to $916,000 in total costs for FY15, $750,000 in total costs for FY16, and $833,000 in total costs for FY17. For the UH3 phase, application budgets are limited to $1.25M in total costs for FY18 and FY19.
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?
Basic, in this case, does not necessarily mean testing human blood and/or tissues or conducting research in animals. In fact, conducting research in animals to accomplish any of the target validation steps or objectives of this SOBC initiative would be considered out of scope. Scientists with expertise in the fundamental mechanisms and patterns of behavioral and social processes relevant to health and well-being are likely to have the requisite expertise required to meet the objectives of the SOBC RFAs. As is the case with basic biomedical research, basic behavioral and social sciences research does not address disease outcomes per se. Rather, it is designed to elucidate knowledge about underlying mechanisms and processes, knowledge that is fundamental to improving the understanding, explanation, observation, prediction, prevention, and management of illnesses, as well as the promotion of optimal health and well-being. Please see http://oppnet.nih.gov/about-faqs.asp
for more information about the NIH definition of basic behavioral and social science research.
43. I’m still confused about how to study adherence in these applications. What are the expectations regarding how adherence is studied?
We have received many questions about how to address adherence in these UH2/UH3 projects. As noted in FAQ #6, non-adherence to medical regimens is a major public health problem that may benefit from the experimental medicine approach promoted through these UH2/UH3 RFAs. In FAQs #7 and #30, “medical regimen” adherence is defined as the adherence to prescribed medications, screenings, immunizations, behavioral regimens, etc. prescribed by a health professional or emanating from a health authority, such as a CDC guidelines. This defines what a “medical regimen” is, but does not specify how adherence to that regimen should be operationalized or how adherence should be defined. It is up to each applicant to specify how “adherence” to such a “medical regimen” (i.e., prescription, guideline, or recommendation) is operationalized, for the purposes of the application. Some forms of adherence may require maintaining a consistent pattern of behavior over time; others may require following through with a small set of specified behaviors. Note that actual health behavior outcomes are not required until the UH3 phase (though there is no prohibition from assessing them in the UH2 phase). Given that the UH3 phase is only 2 years, there is no expectation that long-term adherence can be assessed in that time frame.
Applications that do not have a component related to medical regimen adherence will be deemed non-responsive.
44. What outcomes are required for the UH2 phase?
Actual health behavior outcomes are not required until the UH3 phase but there is no prohibition from assessing them in 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?
Applicants should demonstrate the relevance of their selected targets and resulting health behaviors to at least two clinical outcomes or conditions. We expect that much of the demonstration of relevance will be presented as background to the proposed work. There is no requirement to include measurement of clinical outcomes or conditions in the proposed research plan. Testing actual health behaviors as outcomes is not required until the UH3 phase (though there is no prohibition from assessing them in the UH2 phase). Given that the UH3 phase is only 2 years, there is no expectation that clinical outcomes or conditions can be assessed in that time frame.
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?
An attachment called "Team Science Justification and Organization"must
be uploaded in Other Attachments. Although no specific page limitation applies to this section of the application, please be succinct. Applicants may not use this section to circumvent the page limits of the Research Strategy. The following points should be addressed in this attachment and are an important part of the UH2/UH3 application:
• A clear plan of operation for the administrative structure and proposed interactions among the investigators
• A clear description of the collaborative team process that will be used for the work proposed
• A clear plan for lines of communication and exchange of data among team members
• A rationale explaining how integration and collaboration among participants will be fostered
• A clear articulation of the role(s) and responsibilities for each member of the team and how this will provide the requisite synergies for the research activities in the UH2/UH3
• The Team Science Justification and Organization attachment is not in lieu of the additional requirements if the institution is submitting a multiple PI application.
• Applications lacking the Team Science Justification and Organization attachment will be deemed incomplete and will not be reviewed.
If you have already submitted your application without a Team Science Justification and Organization attachment, you can amend your application up to the March 20, 2015 receipt date.
FAQs Specific to the Science of Behavior Change Administrative Supplements (PA-16-344)
47. Who is eligible to apply for these administrative supplements?
Awardees of active NIH-funded clinical research with activity codes P01, P20, P30, P50, R00, R01, R15, R21, R21/R33, R34, R37, R56, RF1, UL1, U01, U54, UH2, and UH2/UH3 are eligible to apply. The proposed research must fall within the scope of the parent award and be feasible and appropriate for the stage/phase and design of the parent project. Non U.S. applicants are allowed. Please note that NOT-RM-16-026 removed activity code DP3 from the eligibility list for PA-16-334.
48. I have a project supported by a CTSA KL2 grant. Can I apply for a supplement?
No. The KL2 is not an eligible activity code for this FOA.
49. What are putative intervention targets?
Putative intervention targets represent mechanisms or processes that are hypothesized to be measurable, malleable, and to play a causal role in producing behavior change. It has been hypothesized that self-regulatory functions, processes involved in stress reactivity and stress resilience, and a range of interpersonal and social processes play causal roles in behavior change, including adherence to medical regimens. If this is the case, then intervening to alter these processes could result in behavior change.
50. Does the intervention need to be an already validated procedure?
Not necessarily. A newly developed intervention can be used as long as the supplement is designed to test how and why the intervention produces and sustains desired outcomes.
51. Is it expected to use mediation analysis to analyze the data?
This announcement defines a mediator as a variable that is hypothesized to be part of a causal chain between an intervention and an outcome, but for which causation has not yet been established. Until a mediator is shown to cause an outcome, it cannot be considered a mechanism of action, but can be considered a putative (or hypothesized) mechanism of action. In contrast, a mechanism of action is a demonstrated part of a causal chain between an intervention and its effect. Following from these definitions, mediators may be tested as possible causal mechanisms of an intervention’s effect, and such tests must be designed to allow for causal conclusions. Also for the purposes of this announcement, the term "target" refers to the putative mechanism an intervention is meant to engage in order to cause behavior change. The expectation is to develop a design and subsequent analyses to ensure the study is properly conducted and will yield statistically valid answers to the study questions.
52. Should one use the Research Domain Criteria (RDoC) approach recommended by the National Institute of Mental Health?
In line with the goals of the SOBC Program, your application should address one of the three behavior change target domains specified in the FOA (self-regulation, stress reactivity and stress resilience, or interpersonal and social processes). Applications should identify candidate targets of interest that fit into one of the three SOBC domains, which could also be included in the RDoC framework.
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?
There is no requirement specifically in this Program Announcement that your supplemental activity would measure the effect of your intervention on the putative mechanism and also the putative mechanism on the clinical endpoint. It would be responsive to measure one piece of that causal chain. It might not be feasible to measure the impact on clinical endpoints within the specified time frame. However, some projects might be farther along than others in the causal chain, which might facilitate study of impact on clinical end points. Measuring at multiple time points could be a strong strategy, but, in some cases, an appropriate design could be to measure targets at just one time point. For example, if you are introducing measures of a target following the beginning of an intervention in a randomized trial, randomization in theory should mean there is no expected difference between treatment arms in the target you are measuring before the intervention, so seeing a difference after the intervention implies the possibility of target engagement. Overall, the idea is to show that whatever you are attempting to do is having an effect on some putative target. Your proposed activities should represent the best science you can do that are appropriate to your parent project. Another point of consideration for multiple time points is that the frequency with which you measure target engagement should be connected to the changeability of that process. For example, if you think the process changes moment to moment, it would be appropriate to measure much more frequently. In contrast, if you are examining a more stable process, then it would be appropriate to measure at less frequent time points. Justify your proposed design in the application.
54. Should the primary outcome be a behavior versus clinical outcomes, such as body composition?
In some cases, you can imagine that a clinical outcome such as body composition is a good primary outcome for the supplemental activity—change in muscle mass for an obesity study, for example. In other projects, it might be that you would not get to an outcome as quickly as that. For example, in a substance use study, you would not have time to demonstrate participants are abstinent for 18+ months if the administrative supplement lasts only a year. However, you could show that more participants are successfully initiating a quit date and abstaining for an initial period of time.
55. Are Principal Investigators able to select broad clinical targets such as the gut microbiome?
Yes, this could be possible. For example, it could be appropriate if the application was for a project on healthy eating where you have a predicted effect on the gut microbiome and later outcomes. The Program Announcement does not specify the clinical targets or particular health behaviors, but the target itself does need to be identified as being in one of the three domains (self-regulation, stress reactivity and stress resilience, and interpersonal and social processes), and clearly connected to one or more health behaviors and/or medical regimen adherence.
56. What is meant by medical regimen adherence?
For the purposes of this PA, medical regimen adherence includes, but is not limited to, the following: adherence to prescribed medications, adherence to prescribed screening and immunizations, adherence to behavioral regimens prescribed by a physician or health professional, including follow-up tests, dietary modifications, etc.
57. Are studies of preclinical nonhuman primates responsive to this PA?
Current NIH-funded research that involves animals as a critical component of a health behavior change intervention may be appropriate. However, research focused exclusively on animal models of human health behavior and social processes are not appropriate for this administrative supplement PA.
58. What sorts of experimental manipulation or intervention techniques are permitted for testing target engagement?
There is no limit on approaches here. Applicants proposing specific techniques should make the case that the manipulation/intervention has potential to engage the target.
59. How many awards are expected to be made for this PA?
The number of awards is subject to the availability of funds. The NIH Common Fund intends to commit $2 million in FY 2017 to fund 12-18 supplements, pending availability of funds and contingent upon receiving scientifically meritorious applications.
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?
The $2 million in available funding is the total amount spread across all the awards. There have been occasions, however, where ICOs have funded additional meritorious supplement awards in their areas of interest, which is yet another reason to be in touch with the Program Official of your award in advance.
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?
Supplement budgets are limited to no more than the amount of the parent award. The actual number of applications funded will depend on the size, responsiveness, and merit of the applications. In many cases, ICOs have limits or recommendations on direct costs of administrative supplements (e.g., in some cases, a request for more than $100,000 in direct costs could trigger an additional level of review, and could make your application difficult to fully evaluate or fund).
62. Would probing the targets using pharmacological probes be acceptable?
The PA does not restrict the types of experimental or interventional methods used to engage and verify the engagement of putative targets. If using a pharmacological probe will provide insights on whether you are engaging particular putative target(s), then make the case in your application.
63. Does this opportunity apply to provider behavior?
Yes, a supplemental application can propose to examine provider behavior, as long as the applicant can make a compelling case that provider behavior is important to one or more health behaviors, that provider behavior figures into an experimental medicine approach to behavior change, and that the project focuses on a target or process that falls into one of the three broad target domains (self-regulation, stress reactivity and stress resilience, or interpersonal and social processes). Including or focusing on provider behavior may add complexity to a test of mechanisms of behavior change, so it may be especially important in such cases to clearly specify the intervention or manipulation meant to engage a target, what the target or process is, how target engagement will be measured, and the effect(s) expected on some proximal health behavior or distal clinical endpoint.
64. Is a grant project eligible if it is not currently part of the SOBC Research Network?
Yes. This funding opportunity is open to any project with an eligible activity code listed in the FOA, whether or not that project is part of the current SOBC Research Network.
65. Are current SOBC Research Network awardees eligible to apply?
Yes. This funding opportunity is open to current UH2 awardees of the SOBC Research Network.
66. Is a subcontractor to an R01 award allowed to apply?
Only the named Principal Investigator(s) on the parent award can submit an application. However, it could be appropriate for the Principal Investigator(s) to apply for supplemental funds for activities that the subcontractor is intended to perform as part of the overall project.
67. Can one Principal Investigator submit two applications for two different R01 parent awards?
Yes, an individual who serves as a Principal Investigator on more than one current award could submit more than one application to PA-16-334, as long as there is only one application per parent award. The FOA states in Section III, 3, that “Only one administrative supplement application per parent award will be considered for this FOA.”
68. Can a Principal Investigator apply for and receive this supplement award if he/she is also applying separately for a diversity supplement?
Yes, if you have an application pending for a diversity supplement, you can still apply to PA-16-334.
69. Are international consultants allowed on the budget?
Yes, international consultants are allowed on the study budget. As with all consultants on NIH-funded projects, their role must relate directly to the project.
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?
Please check with the Principal Investigator of your CTSA grant. Note that the currently funded project supported by the CTSA program must have ongoing funding for the expected duration of the planned administrative supplement. Awards for successful applications in response to this FOA are not expected to be issued until the summer of 2017. Thus, the underlying project must have ongoing support at least through summer of 2018. Additionally, the proposed supplement activity must be within the scope of the ongoing project supported by the CTSA award. Requests for funding for new projects unrelated to an ongoing CTSA-supported project are not allowed 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?
As noted in the FOA, this administrative supplement application may not be used to add, delete, or change the PIs listed on the parent award. Visit the Multiple Program Director/Principal Investigator Policy in the SF424 (R&R) Application Guide for more information.
72. Is there a minimum percent effort that PIs need to include in the budget to demonstrate adequate time/commitment?
There is no minimum percent effort required for PIs on supplemental projects. As with most grant projects, the percent effort should be sufficient to demonstrate scientific leadership of the project, although as noted in the answer to one of the above questions, the greatest portion of an award could be made to investigators working on a subcontract.
73. If an otherwise-eligible grant project already incorporates aspects of the experimental medicine approach, is it still eligible for this funding opportunity?
This funding opportunity is meant to support activities that help fully implement an experimental medicine approach to behavior change research. Activities that add elements of an experimental medicine approach to an existing study (e.g., add a test of target engagement to an intervention trial where none was previously proposed), or that enhance the implementation of an experimental medicine approach (e.g., add a gold-standard measure of target engagement, where a proxy measure was initially proposed) are eligible to apply.
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?
Yes, as long as the activities proposed are considered within the original scope of the parent project, proposals to recruit additional participants for a sub-study are acceptable activities for this PA.
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?
Yes, it is acceptable to apply for a supplement award before a parent project has begun recruitment. However, it is important to include a detailed timeline that corresponds with the 1-year award period, as awards are expected to be made by September 1, 2017.
76. Can one request a delay in the supplement if awarded until a substantial number of participants have been enrolled?
Because only funds from fiscal year 2017 are being used for this FOA, no delayed awards will be issued. But do see the answers to previous questions concerning whether supplemental funds could be used to support activities after the one year we are making the award for is over; in most cases, funds would still be available in future fiscal years.
77. Is there a limit to the amount of funding requested for an administrative supplement project in response to this program announcement?
While there is no limit for requested budgets, applicants are encouraged to consider activities feasible to conduct during a 1-year supplemental period, and to make sure budget requests are commensurate with proposed activities.
78. My project will be in a no-cost extension by the time these are awarded. Can I still apply?
Projects must have sufficient time remaining to allow for completion of the supplemental work. The project and budget periods must be within the currently approved project period for the existing parent award. Be sure to talk with your PO about IC-specific rules concerning the timing of a supplement award within the parent project period. ICs handle supplementing projects in no-cost extensions differently so it is best to discuss this with your Program Officer first.
79. How will these applications be reviewed?
Applications received for PA-16-334 will be reviewed first by the Program Officer of the parent award in accordance with Institute-specific policies and procedures concerning administrative supplements. In the second stage of review, members of the NIH SOBC Working Group will review each application for responsiveness to the FOA and scientific merit and make recommendations to the NIH Common Fund Program. The NIH Common Fund Program will make all final funding decisions.
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?
No. Reviewers will be instructed to evaluate the content of the supplement application alone without referring to the parent grant. It is imperative to first ensure the supplement is within the scope of the parent grant (confirm with the Program Official), and provide enough detail about the parent grant and indicate how the proposed supplement aligns with or enhances the goals of the parent grant.
82. How long should my application be?
Per the FOA, the research strategy portion of the application is limited to 6 pages.
83. What does the six-page research strategy need to include? Is there a list of required elements?
The six-page limit is for the research strategy portion of the supplement, which in any NIH application is supposed to address the review criteria listed in the FOA: significance, innovation, quality of investigators, environment, and approach. Applicants are free to organize the research strategy portion in a way that makes the most sense for the project and presents the best case. Because these are supplements to existing awards, it might be reasonable to show preliminary results from the parent award project, but this is not required.
84. Is there a one-page specific aims in addition to the six pages?
All aspects of the research strategy, including the description of the specific aims, must fit within six pages. The application does not allow for an additional page to describe the specific aims.
85. Can I apply for multi-year funding for the supplement?
No. This funding opportunity is for a 1-year supplement in FY2017 only.
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?
Administrative supplements are added to current parent award, so whatever the current award is allowed to do, the supplement funding can be used for that too. In other words, if the parent award receives a no-cost extension, the supplemental funds and activities could also be part of that extension. The SOBC Program will only make one award in fiscal year 2017; additional money will not be awarded in subsequent years.
87. If a parent study has more than 1 year remaining, can the supplement funds be used across the remaining years?
Administrative supplements are added to current parent award, so whatever the current award is allowed to do, the supplement funding can be used for that too. Discuss the project period with your Program Official because the specifics of this question might depend on ICO-specific policies and procedures for administrative supplement awards.
88. Does the supplemental project have to show change in a clinical endpoint?
No, not necessarily. For many clinical endpoints, it might not be reasonable to expect change within a 1-year timeframe coinciding with the supplement period. It is acceptable to focus on engaging the putative mechanism/target in the study itself, but the application should make a clear case for why the putative mechanism is important (e.g., it is related to one or more clinical endpoints).
89. When do you think I need to talk to my Program Official and one of the scientific contacts?
Early and often. More seriously, engaging your Program Official early in the process to find out if you are even eligible, or whether the ICO would be comfortable supporting your application, is just the very least you can do. Similarly, engaging one of the scientific contacts early on might make the difference between proposing something that would not be competitive for this FOA and something else that would be extremely competitive. You should talk to us often because as your idea changes and evolves, we may have different opinions on how best to improve it, or make the strongest case for your projects.
90. Who should I talk to if I have more questions?
Contact the Program Officer assigned to your parent award AND one of the scientific contacts listed in PA-16-334 to discuss your application prior to submitting.